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Medtronic Paradigm Recall: Quick-Set Infusion Sets for MiniMed Insulin Pump

Medtronic Inc. has recalled three million disposable infusion sets designed for their MiniMed Paradigm insulin pumps after discovering that some of them could deliver incorrect doses of insulin, potentially leading to injury or death.

The Medtronic Paradigm recall involves one lot of Quick-set infusion sets, which are disposable plastic tubes used to infuse a diabetes patient from the Medtronic insulin pump. They are usually replaced after three days. Medtronic issued a press release on July 10 alerting users that approximately 2%, or about 60,000 units, from one lot of its infusion sets have a defect that could give too much insulin to the patient.

The affected infusion sets have a lot number starting with “8” marked on the product box label and on each infusion set package, with the reference numbers MMT-396, MMT-397, MMT-398 and MMT-399. The defective infusion sets do not vent air pressure properly when delivering an insulin dose.

The sets were distributed throughout the United States and to a small number of countries outside of the U.S., such as Germany, Mexico, Brazil, Great Britain, Canada and the Bahamas. There have been no reported injuries related to the insulin pump infusion set recall, but the defect has the potential to cause fatal injury.

Last month, the FDA issued a warning letter to Medtronic about Synchromed and MiniMed pump problems. The agency warned the company that it needed to fix quality control issues in its Puerto Rico plant where the products are manufactured. According to FDA investigators, the plant had a wide range of problems that included lax testing of products for defects, proper record keeping, and employing someone with only a high school education and some special training as a medical expert for determining the danger of defects.

Medtronic is offering patients replacement Quick-set infusion sets for the MiniMed Paradigm insulin pumps in exchange for the defective ones at no charge. However, product liability lawyers who are investigating potential lawsuits for Medtronic insulin pump problems caused by the recalled Quick-set infusion sets, indicate that any units from the recalled lots should be preserved for litigation purposes if a serious or fatal injury has occurred.

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71 comments

  1. bart Reply

    are these infusion sets fda approved

  2. jeff Reply

    My daugfhter was put in ICU a month ago ($20,000 in hospital bills). She was suffering from ketonacidosis. It is clear it was casued by her infusion set; she used lot number 8. Since switching sets, she is doing fine.

    We need a lawyer. I haven’t seen reports of other victims–are you out there?

  3. Peggy Reply

    My son just got out of ICU on Saturday. He spent 4 days in ICU. He was admitted for DKA and dehydration stemming from this sets. We just received the letter via UPS about the recall and the new sets. Since he changed his site and started using the new quick sets his blood sugars are back to normal, but, he continues to have severe headaches. Our daughter is diabetic also and was having the same symptoms and was using the same quick sets that started with “8”!! Anyone else having any problems?

  4. Pat Reply

    My daughter was also placed in the hospital for DKA for high blood sugars and in late 2008 was in the hospital for 5 weeks for low blood sugar. The doctors said she was trying to kill herself by giving herself to much insulin or not enough. The doctor went as far as having her Baker Acted. She has suffered a lot of emotional stress. And She still has not been notified of the recall, I found it online by chance.

    We also need a lawyer!

  5. Ginger Reply

    My grandaughter 17 years old, diagnosed with Type I at nine months. She just suffered a Grand Mal Seizure, and had used a box of the series 8 supplies. Biting down during this seizure, she dislodged a lower tooth and cracked her mandible. The pain is severe and the seizure was life threatening. She depends on her insulin and pump for her life everyday and minute. Her disease is not new for her or the entire family, and this was caused by the infusion set and not through her own actions. She recieved a letter for the recall on July 7th and it was too late.

  6. Wendy Reply

    My son died on 5/19/09, age 21. He was using this product.

  7. Neriah Reply

    They are FDA approved. I was not hospitalized but if there becomes a lawsuit out of it then count me in. I trust my health to this company and they dont even have good quality control on their product? Its meant to make life better and save lifes, not destroy them and cause death.

  8. barbara Reply

    My husband (type 1) has been using the pump since 2001. Recently he has not been able to control his sugars (too high). Complained to doctor, changed site, basal rate, but nothing worked. April 30th, blood vessels in his right eye burst causing hemmoraging which was due to high sugars. He had laser surgery in his left eye in May. He allso used lot 8 and since using replacement set has his sugar levels under control.

  9. Julie Reply

    I, too, have been seriously harmed through the use of those infusion sites. I was so far into ketoacidosis that my legs were mottled, my kidneys had failed and when I came out of the coma I was temporarily blinded. I spent nearly 5 weeks in the hospital-most of the time in ICU. Even with health insurance I incurred serious debt-not to mention the trauma I put my young daughter and family through. Medtronic needs to take responsibility for their product!!!

  10. Lynn Reply

    My son had the same problem about 10 months ago. He was in the hospital with ketoacidosis. They almost put him in ICU, but thankfully he responded to the IV just in time. We knew it was the infusion set at that time. Minimed knew, too, and called me several times about it. I can’t believe it took them this long to do a recall. It’s scary to think of how many others had to suffer.

  11. Lauren Reply

    I got on a plane with one of these sets last week and it resulted in mass overdelivery of insulin and four hours of severe low blood sugars. It only stopped when I injected emergency Glucagon to reverse it. The very next morning I discovered that I was running high 500 to 600+ blood sugar levels until lunch time. This had lovely consequences as well, including LOTS of vomiting and illness (ketones!).
    Why did Minimed not CALL patients about this? I could have died on this trip! Thanks, Minimed! Is there a class action lawsuit for this or what?

  12. Donna Reply

    My sister has had numerous problems with the insulin pump. She had numerous spells.. couldn’t figure out what was happening. Discovered she had all lot 8…. Yes,,, we need to start a class action suit!!!!!

  13. Trina Reply

    My mom passed away January 3rd 2009. I was told it was natural causes, she had only been on the pump for 4 weeks. I questioned the pump but was told it wasn’t the problem. I got a letter in the mail yesterday about the recall, she too was using lot 8.

  14. Jennifer Reply

    I let my blood sugar run high these days since I am so terrified of another 29 or 23 and unconsciousness again. I live alone. While I am happy to find out I am NOT a bad diabetic and it was the fault of this product, I can’t help but wonder how many months of my life are gone a a result of this Lot 8????? I have been higher than ever before and lower than ever before. All because of lacking quality control in Puerto Rico where teenagers are given the responsibilty of creating the product that gives or takes my life from me. Who thought it was okay to lay that kind of responsibility on some kids?

  15. Betty Reply

    Why am I just finding out about this?? I called to order new supplies from Edgepark and was told there would be a little bit of a delay since the problem with the infusion sets. That was the first I heard about it. Thank you Edgepark. I’ve been having trouble regulating my blood sugars for a while now. I have one box left with the mentioned coding, so I don’t know if the other two boxes were from this lot or not. I feel really let down by Medtronic. Why didn’t I hear about this from Medtronic? I’ve been very depressed and hopeless in trying to regulate my blood sugars. My two doctors have been mystified by my lack of interest in getting my blood sugars regulated.

  16. cheryl Reply

    I have the lot number 8.. we went to oklahoma and my sugar dropped so fast and hard that the last thing I remember after all the glucagon and honey and mints I ate was that I twisted the pump off of my stomic and it hit the floor. I had several more episodes and put it in the drawer. I went back to the pens. When I got the letter I called the company and told them I wanted the money back I paid for the pump. I am afraid to use it now. They said no way and to send them the bad sets. I am hanging on to them in case there is a lawsuit. I am still paying for the pump and cant use it now.

  17. Brenda Reply

    My daughter has been using the minimed for a year and a half with great results. I still have great faith in Medtronics. My father also has one of their products. He has a defribulator and just last week it SAVED his life.

  18. Karen Reply

    Crap and of course I mailed mine back instantly because they said they would not send me more until I did so.

    I am soooo angry

  19. ali Reply

    SOme of your stories are very sad, I am sorry. I was curious though since the methosd is to take your pump off after 3 lows or 3 high sugar readings, why has this not been figured out sooner.
    my daughter as been on this pump and has lot 8’s (many) but bnothing came of it. I just know that in the past, we were always able to determine if it were the pump causing the issue with the sugar due to not using the pump and going back on shots. The blood sugar ceases to be normal in a few hours or a half a day, somewhat. This si weird. I know trhere were planty of occasions that we took her off the pump becasue her blood sugar was funky. THere have been a handful of bad sites, not just the product but the resivour twisting inside , and so on.

  20. Jacy Reply

    My father just spent a week in the hospital due to insulin shock resulting in brain damage all thanks to a plastic tube.

  21. Victoria Reply

    I had fallen and hit my head numerous times from low blood sugars. A couple of times, I was knocked completely out since I was on concrete when I fell. Since I live alone and my family didn’t want me to stay in my home, I finally gave in and went to the ER on March 13th of this year. I fell in the hospital bathroom, broke my glasses and had to have 7 stitches put over my eye. My BS was under 10. After having every test imaginable, the doctors told me to stop wearing the pump and get a new one. I have and have had no other problems. Had my father not seen the article in the paper, I would have never known. The left over infusion sets that I had from my Medtronic pump were the lot starting with an 8. I was so relieved to know it wasn’t me and something I was/wasn’t doing to take care of myself. I was on the verge of having to sell my house and move in with family. It would have been nice if Medtronics would have contacted us. That’s adding insult to injury!

  22. Adriane Reply

    My medical supply company said there is a class action suit in the works. Don’t accept replacement product if you want to participate. Also call the FDA Hotline for Minimed Complaints at 1 800-337-1088. Minimed has also ‘suddenly’ stopped serving smaller supply companies. They are plain greedy! They wanted more than BCBS pays for pump supplies, so my supplier would have had to sell them at a loss. I also recently read that a Medtronic rep can make $500,000 a year! And they treat their patients this way. Shameful.

  23. Tiffany Reply

    For a while now I have had a hard time with my sets but last month I went on vacation to SE New Mexico and my sugars got worse. I was high alot and over 2 days I couldnt get my sugars down I went out for a second due to dehydration and high sugars. I was taken to the ER and was fine after insulin and fluids. I had 8 trys for a IV and they hit a nerve or something in my arm when they tried to get a IV in to help me but couldnt cause I was so dehydrated. My arm still hurt a month later from the IV. I am so scared of going low biggest fear of my life. I dont want to use to the pump anymore. They wont sen dme any new sets till I return them all. Why am I paying thousands of dollars for a ER visite that I prolly didnt call. Oh the day I got the recall I was at the Zoo. I thought I keep getting low cause of the heat but I had to have cotton candy, then oreos, then a soda, then icecream, lunch, a candy bar all day with no insulin cause I keep getting low. Now I know it was the pump that day to. It was a new set that day before I left. No way in hell cuold a diabetic eat that much with no insulin and be low. My friend had to sit me down and force feed me grapes with six little kids looking at me to make sure I was okay. I was very scary for us all. Thank god I didnt passout. I had horible cramps and stool for eating all that crap I am not use to eating.

  24. Marion Reply

    My 26-year-old daughter is in the hospital for the 2nd time in 3 months. She was admitted into ICU for each admission because of being in DKA. She also has gastroparesis so the downward spiral has been especially hard on her. Each of these visits has had her in the hospital for 3 weeks or longer (she’s still there now).

    She also had severe problems resulting in high blood sugars no doctor could figure out the last time the wires were recalled. I know MIniMed is a multi million dollar company but you’d think that if they experienced a recall for a certain problem, they wouldn’t have the same thing happen again several years later. At least now we are living in Canada instead of the States (where we were living before when the previous recall took place) so we don’t have to worry about the costs of these hospital stays but we do worry about the toll this is taking on her body. And now she has a new pain in her abdomen that no doctor can figure out. How many months can someone experience high blood sugars without it doing serious damage?

    I am so angry.

  25. sandi Reply

    I am a victim also!!
    In May of 2008, I went to the ER and spent 2 days in ICU. I was admitted for DKA, dehydration and projectile vomiting. My blood sugar exceeding over 1000 and had to “fight for my my life”. As a matter of fact, the ER doctor told my family that they did not think I was going to make it through the night.
    I was using the infusion sets, Lot #8. I had been experiencing extremely high blood sugars (over 600 or off the meter blood sugar readings) for almost a year. I called to complain to Medtronic Minimed about the Insulin Pump AND the infusion sets, many times. They replaced Paradigm Insulin because they said it could have been due to a faulty sensor or a bad motor. The New and replaced Medtronic Minimed insulin pump, still was reporting “No Delivery”. The problem was in their infusion sets lot #8. It was not delivering the insulin. My doctor was made aware each time I had problems because it showed in my A1C which was 9.2. My doctor said that was enough. He immediately removed me off the insulin pump in Apr. 2009. I am now taking 4 injections of insulin per day. Speak to your doctor and find out if there could be any long-term effects from this. I still have the 3 month supply from Medtronic Minimed, ALL Lot #8 infusion sets ordered just prior to my doctor removing me off the pump. I have not returned them yet.
    Medtronic Minimed Paradigm Pump and the Infusions sets were my LIFE LINE. I have been a “Brittle” Diabetic since 1969 and was totally dependent on these products. I am a type 1 diabetic that cannot live without insulin.
    I believe Medtronic Minimed should be held accountable for the suffering, medical expense incurred, physical and emotional damage plus any short or long-term medical problems that have occurred or may occur in the future from the direct result of their defective products. Why should they get away with just sending out a letter of notification to us and that’s it!!!! No repercussion, No accountability, No Remorse??
    I cannot understand WHY they didn’t follow up immediately on serious and life-threatening complaint made. Why it took them so long to recall a defective product?
    I received this also:
    July 13th, 2009
    Medtronic Inc. has recalled three million disposable infusion sets designed for their MiniMed Paradigm insulin pumps after discovering that some of them could deliver incorrect doses of insulin, potentially leading to injury or death.
    Don’t you think we have we have all suffered enough?
    If there is a class-action lawsuit out there, I want to participate.

  26. Lisa Reply

    my father died July 14, 2009. He was using this product. He went to the hospital nonresponsive 7/5. The recall letter was delivered to his house 7/10.

  27. Patricia Reply

    My son had a grand mal seizure caused by too much insulin from his Lot 8 infusion set. I contacted Minimed and asked them to reimburse his medical expenses. They sent us the forms. I too am furious that they did not call us instead of writing. He could have died!!

  28. David Reply

    Two comments: 1) I have been using these products for several years and have noticed over time that more than 2% have been defective because there has been over delivery of insulin or very little if any at all; I would notify Mini Med and they would have me send it in and replace with another one as far back as two years or longer; my A1C’s climb and my Doctor was shocked that my diabetis was not better controlled and i was having so much trouble. I feel the company should have notified all users in a timely fashion. 2)My son’s father-in-law died in his sleep a few month’s ago while using these products. Need an attorney’s help

  29. Lori Reply

    My husband was using all lot 8 infusion sets and was wondering what was wrong with his diabetic control. He died March 12, 2009 from diabetic ketoacidosis. Wow. I was shocked when I opened the letter for him after his death and found out about the recall. Talk about too late! I still feel the sting from that letter knowing that the mistake of the company killed my husband.

  30. Andrea Reply

    I had lot 8 infusion sets that I sent back and one person said dont send them back and accept the replacements if I want to participate in a class action law suit. I saved a box and some lose ones. What else am I supposed to do? I need them and they were paid for and they wont return the money to you.
    I suffered high blood sugars over 500 not knowing why. I would test 8 to 12 times a day and had to do a self injection with a syringe several times. My doctor and I had questioned everything I did for several months because I was so high and dehydrated. I had blurry vision my averages for my A1c were higher I had nausea, fatigue and disorientation
    I called medtronics and asked how long has this been going on and the person told me a few weeks. I told her that I had some Lot 8 boxes from a previous order 3 months before this last order so it has been longer then a few weeks.
    It would be nice to have gotten an honest answer. I now have gotten my sugar level averages down since they sent me som new sets.
    I think they should be sending you all of yor replacements back to you at once since they have already been paid for and not evrey 3 to 4 weeks as they said they were going to..
    This has been pretty scarry and the stress of not knowing what I am doing wrong and always feeling so crummy!! I hope they have fixed the problem. I am lucky to still be alive!

  31. Edith Reply

    My husband Jim, also experienced severe highs and lows with his blood sugar…He was also using the recalled 8- series..We could not understand why this was happening because we were told that the pump would prevent such wide swings in his blood sugar…We are really disappointed that a company we had such faith in for the well being of my husband has such low standards…Trust was what we had..now we fear the product and possible future complications..What guarantee do we have that this will not happen again…and will he survive another incident such as this…My husband means the world to us…and to think Medtronic placed him in severe danger with a defective product…something should be done about this…

  32. Joe Reply

    My 18 year old son had a seizure July 4 at 10am. We rushed him to the Hospital, His BS was 69 at the time. All tests were performed with no problems found. His endo thinks it was a diabetic seizure. He also was using the Lot 8 sets. I would love to see a class action suit against MM.

  33. tiffany Reply

    my mom went into a diabetic coma due to the pump malfunctioning…..then had a stroke…and was hospitalized for 4 days and cannot walk or talk properly…..she has speech theropy, physical theropy, and occupational. it has put my family through alot….my dad hasnt been able to go back to work bc she cannot be left alone at any point…..all bc of the insulin pump malfunctioning!

  34. Dan Reply

    My girlfriend was admitted for DKA, dehydration and projectile vomiting a couple of months ago. A couple of weeks ago I woke up in the middle of the night to find her dying from low blood sugars as a result of Medtronics’s defective Quick Set Infusion.

  35. ABBEY Reply

    I have been on a medtronic insulin pump since december of 2000. i switched to the paridigm pump in dec of 2007. since then my a1c has done nothing but get higher and higher my most recent a1c was 9.8%. i have been calling medtronic since Jan 09 stating that these infsuion sets were not working right, They insisted every time that it was operator error and that i needed to change the site mor often. i am absolutley disgusted with medtronic and refuse to ever use there product again or return the unused lot 8 quick sets

  36. Ron Reply

    My 22 year old son ended up in a diabetic coma after flying to NY. He went to sleep after the flight, which we believe caused an air pressure change and the malfunctioning of the infusion set (lot 8). He went extremely low due to increased insulin and would not wake up the next morning. We had to call EMS who rushed him to the emergency room at Belleville hospital. While waiting for EMS he started having convulsions and his breathing was becoming frighteningly shallow. If my other son (who is 21) had not been in the room with him and called 911 quickly, he more than likely would have died within the half hour. The “voluntary” replacement sets arrived the day he was flying. Ironically, he was in NY to attend a Yankee-Tiger game that was part of a package we won at the JDF Charity Ball in Michigan.

  37. Elaine Reply

    My husband, a self employed painting contractor and a pumper for approximately 3 years, lost consciousness while driving his commercial cube van to work on the morning June 25, 2009. Minutes prior to leaving the house his BS reading on his BD Meter was 161. He drove approximately 10 miles down the road, before his truck crossed over the road into oncoming traffic and struck the guard rails. (The insurance company opined his commercial van as damaged beyond repair). When the EMT’s arrived a short while after the incident, his BS reading was 24! He was stabilized and evetually was driven home. Not knowing about the problems with Lot 8 infusion sets, he left his pump in place after the incident. Later that day, at approximately 2 pm he experienced yet another major hypoglycemic attack and was rushed to the hospital ER via ambulance, where he was admitted for testing and observation due to haed injury sustained during the MVA. He made the decision to discontinue use of the pump after this incident. He had been experiencing major problems with low blood sugars for several months prior to this incident. Insomuch as he had discontinued use of the pump, we did not read the e-mail from Medtronic announcingthe recall until the evening of 7/29/09. We immedicate checked the 7 boxes of infusion sets in our possession and found that the lot numbers for every one of them began with the number 8! At least now we know what caused this potentially fatal adverse event.

  38. Tara Reply

    I am dumb-founed to think that those of us that have been so horribly effected by these defected infusions sets are not being given the same legal rights as those who had close-to death experiences/long tern effects. Don’t the attorneys know that for every high blood sugar episode kidney cells are killed….and don’t regenerate. I was treated in the ER, and will now have to wear glasses because of 3-4 weeks of blood sugar 300-600 and even higher. I can’t tell you how many times my meter read “HI” (which means over 600) over the last month or so. I have been using the lot 8 infusion sets. I also thought that my sites were probably bad. Hearing my 7 year old son saying, “Mommy, I don’t want you to die” was heartbreaking. If these attorneys only knew how horrible weeks of high blood sugar makes you feel, and understand the irreversable damage it does to your kidneys; they would be more likely to represent us in a lawsuit. I feel so very blessed that I didn’t go into a coma or die. I’ve always been told ( by doctors ) that blood sugar over 300 is high enough to put anybody in a coma. My ketones were exremly high during this time. The vomiting and nausea was awful. Because of all the ketones in my urine, i developed a boil ( the size of a large pecan) in my grion area. That was in June….it still hasn’t completely gone away. Needless to say, this caused weeks of problems with intamicy with my husband. According to the research I did regarding product recall lawsuits , not only are we entitled to something for pain, stress & trauma; but our family should also be entitled to something if it has caused problems with our relationships. I am not a greedy person; nor am I sue-happy. But feel like those of us who had to endure this should be entitled to something. I need an attorney that is willing to stand up for me and my rights.

  39. Kara Reply

    Minimed’s negligence is inexcusable!! Not only are they placing diabetics at risk from a subpar product, they are also demanding the return of a product and not immediately supplying a replacement. APPARENTLY, they have NOT manufactured enough of the infusion sets to replace the ones returned! This is a lifeline that requires immediate and continual use. It’s like a doctor telling you “Oh we’re going to place your pancreas/heart/liver in this box for a few days or weeks and we’ll send another one to you sometime soon.” Who’s showing accountability for this and who’s to say the replacement won’t have the same risks???!!! Also, who’s absorbing the costs of the hospitalizations, syringes and additional insulin required while you WAIT(with no answer) for the big arrival of a product that no one knows when to expect!!!!!!!!!!!!!!!!????

  40. Stan Reply

    I’ve been taking insulin since 1964. I have no serious complications associated with having Diabetes for this many years. When I go to the MD for check up he brings in the Interns for educational review as I too have an analytical scientific college level background and we discuss issues and resolve choices for the best possible quality of life.
    Three years ago I switched from shots to the Medtronic pump. I had the initial individual basal challenge set up with some what predictable control issues at first. Success came with my MD-Diabetic Specialist assistance; we were seeing better control results for apx. two years –until the Winter of 2008. Then for some unknown reason my blood sugar levels were sporadic and my statistics were not showing any assignable trends except the pump was not working. I was feeling horrible and my job performance was drastically affected. During this time, I called Medtronic many times about my Medtronic pump and followed their advice. Still these attempted corrective actions did not work. My blood sugars were out of control from highs to lows. I was using the Paradigm Quick Set MMT-399, lot 8200422 and others with the “8” lot designation. I counseled with my boss told him of my diabetes issues and two weeks later lost my job.
    I quit using the pump and went back to four shots a day early 2009. I felt better and experienced vast improvement. I have not gone back to using the pump.

    I received the July 2009 notice of recall and request me to return any and all of lot #8… in the mail. Upon receipt, I contacted Medtronic and spoke to their Customer Service person again whom acknowledged all our 2008-2009 prior conversations noted on their computer files about the defective pump issues and with letter in hand I now have an identifiable root cause.
    I request Medtronic refund my money back in exchange for the Lot #8 product I still posses and they have admitted as defective.

    I am disappointed in Medtronic intentional delayed refund response action, their Quality Assurance, and most of all ANGRY at the FDA system for letting something like this happen! Just think, if this were a USDA-FSIS product like Jack in the Box, Hudson, TAV, there would be a major recall initiated, immediate Front Page News issued across the USA, all Medtronic business would be placed on HOLD; all “lot 8” product would be immediately retrieved ASAP with exchange for acceptable product or customer refund. Think back to those past food incidences–third party auditors (like FDA Compliance) immediately deployed documenting /verifying returns against production records to assure all defective product is retrieved with a sence of containment urgency would be done by now. But no I see some Medtronic Quick-set product for sale today on EBAY. What a joke. Wake up America and FDA!
    I hope Medtronic sends my requested refund soon or they will have to count me in with this group loaded with science based facts,,,,, not just emotional liable attorney hype with the only business vision to sue for profit against Medtronic mistakes without fixing the real problem(s).

  41. Lynn Reply

    I have sufferred symptoms similiar to many of you. I was in the intensive care unit on an insulin drip last April and was poked and proded for several days with a discharge summary of hyperglycemia-pump malfunction. When I finally received notice of the recall and demanded reimbursement for my medical expenses, Minimed has put me through the ringer demanding written statements. bills, receipts, insurance EOB’s etc. It will cost me hundreds of dollars to print all my medical records. This is open and shut to me, does anyone have any suggesstions on how to handle this. I just want what was taken from me!

  42. Thomas Reply

    I have had 3 new pumps since September 2007 and have had numerous low blood sugar incidents since then, some requiring hospitalization and ambulance transport. From one of the replacement pumps I copied its history, which recorded a large amount of insulin being dispensed throughout the night while I was sleeping. The manufacturer’s response was “this never happens.” In April 2009 the manufacturer blamed erratic doses on a CT scan, which does not affect the insulin pump. On July 9 my wife found me thrashing around on the living room floor because of a low blood sugar incident; after I had been stabilized by ambulance personnel and taken to the emergency room, the nurse could not get a temperature reading and had difficulty obtaining a blood sample. Two days after this I received the recall notice. Needless to say, I and my wife are beyone paranoid about my continued use of the insulin pump.

  43. shannon Reply

    i had the same problems . ive been diabetic for 15 years and never once had a sugar so low that i had to be awakened by EMS working on me with my 9 year old son watching. i was so sick i almost lost my job and i was pregnant and my daughter was delivered early due to “unexplained high sugars”. i went on the pump to better control my sugars and now i think about what damaged was done to my body that i wont see til years down the road

  44. Chris Reply

    I’ve been on the Medtronic insulin pump for 20+ years and this is my 6th Medtronic pump. I have never had an A1c over 7.3. over the last 6 mos. my A1c’s went up to 8.0! After finding out that I had been using “recalled Lot 8 quick-sets”, I was appalled as all these posters are. It’s been horrendous with the roller coaster ride I’ve been experiencing. Sugars going down in to the 40’s. I even threw a bottle of insulin out because I thought that was the problem. Fortunately, I saved a box of these infusion sets. I consulted a personal injury lawyer and he says, since the FDA approved this, we don’t have a case. Be careful about “loan-shark” lawyers. My sympathies to those who lost a loved one and for those that endured a hospital stay.

  45. Amy Reply

    My 10 year old has had major problems the last couple months with what we thought was the pump. We called Medtronic several times where they tried to “troubleshoot” the pump over the phone. They never found anything wrong. I distinctly asked them how they can tell if the basal dose was getting into the blood stream, and they said they have no way of knowing. Now I hear about the recall and realize we have been using those sets, which we order 5 boxes at a time, for a long time! His A1C had gone up to 7.9 and our doctor even made us come in because they thought WE might be doing something wrong! The rollercoaster of blood sugars is now over, but I am sick with worry over what this has done to my son. I am very angry!

  46. Betsy Reply

    I finally let my 14 year old daughter get on the pump april before last and she stayed in constant ketosis . Missed 67 days of school and i had to check her out about another 30 or more times. Her blood s to myself when the previous person said they threw away one bottle of insulin… Try about 10 or more , numerous tubings and constantly changing site. Doing everthing the endo would say to and i am a nurse so i knew what to do .We just kept trying to hang in there with the pump but i finally started telling people this pump is killing her. I had fought going on the pump for 3 years because i am a nurse and have seen what a man made machine can do to people. (Bolus them) The first thing you hear when you enter a hospital hall is an infusion pump beeping. I was afraid to trust them and apparently i was right. It damaged her physicaly and psychologically in ways too long to and personal to even begin to tell would take pages . When we got that pathetic i’m so sorry card from the pres of the company i was livid.and called them.. I would so love to make them pay for God only knows what king of damage being in ketosis for most of a year will cause long term. I kept yellling at her thinkilng maybe she is doing something wrong but between me and the school nurse she was always with one of us. She desperately wanted some freedom at fourteen and thought the pump would give it to her and all it did was make me an armoured guard . I pulled her off of at the first of april . We got our letter the same day every one else did. Why did the previous person say the fda approved and no one can sue. How does that have anything to do with it. I refused to send my tubing back in case it was needed for evidence but they sure wanted it back – so it couldn’t hurt anyone else… right. Thank God I pulled her off the pump when I did.

  47. Allison F. Reply

    I am still in college and looking to find a lawyer to help with either a class action lawsuit or a personal lawsuit against Minimed. I have stories similar to all of those posted below. People do not realize that the damage done to us can be irreversible. Minimed needs to compensate us somehow for this injustice. Please help if you can!

  48. Debbie Reply

    My 28 year old son was diagnosed with Type 1 Diabetes at the age of 18 months. He went on his first minimed pump when he was 16 years old. He is now on his 4th pump. On July 11th he was taken to the ER by the paramedics after passing out and having a seizure. He had been trying to get his blood sugar down for the previous 24 hours which has increasing climbed to over 600 even tho he kept boulusing insulin. When he started having the seizure his blood sugar reading was 85…a good count. After feeling “low” we tried giving him pepsi since we were at a graduation party and not close to home. He was unable to swallow and began to choke before he started the seizure and finally vomited. Thankfully there was a paramedic and the party who took over and called for an ambulance. He was transported to the hospital and they were baffled at what had happened. We too threw out the insulin thinking something must have been wrong with it and he changed his sites. A week later he received the letter from medtronics. Our family spent the week agonizing over what had happened and worrying it could happen again at any moment since we couldn’t figure out a reason for this problem. After dealing with Type 1 diabetes for over 26 years we have always been able to figure out “in hindsight” what may caused a high or low blood sugar or reaction. This was so stressful and confusing until we got the letter. I was so relieved to “have an answer” at first but now worry about the reliablility of this equipment. If this happened once can it happen again. We were very fortunate and thankful that Kris rebounded from the seizure like he did. He experienced headaches for weeks afterwards and his blood sugars were erratic. HE seems OK now but what long term affect does this have on him?. Where do we go from here? The pump has been such a positive change in his life it would be devastating to go back on multiple injections but this is scary!!!

  49. Terrie Reply

    my husband has been hospitalized 2 or 3 times in the last 18 months and ‘up’ and ‘down’ so much its been a nightmare. then this big push to return infusion sets by supplier. Yes I’d like to know if theres a lawyer.

  50. Mr. B Reply

    I too rely on these infusion sets and I trust that they have been thoroughly checked and then certified by a quality control.

    Last year for St. Patrick’s Day my wife and had the good fortune of being in Ireland for a business conference my wife attended. She is an executive, therefore her employer paid for everything […that is the great fortune.] One evening while I was sitting in the lounge with her team mates and all of us drinking wine or what ever, I seemed to have blacked-out.

    I had been experiencing a rapid series of failure of the infusion sets, more so than I had expected, on top of many bouts of hypoglycemia which I had written this off as jet lag and the resetting of my personal time zone and the pumps timing.

    Three months prior, my wife had to call paramedics due to my extreme low sugar which had just appeared out of the blue. Infusion set?

    On the evening that my lights went out in Ireland, I only remember gaining cognitive ability after someone gave me a sugary soda. Please note that my wife was in a meeting and this all transpired while she was not there and she in fact was the one who ultimately gave me the soda, albeit an hour after I blacked-out.

    As it turned out, there was a police event with that very evening in that resort and the police had said that I was incoherent and therefore I was drunk. They had taken me up to our room and it was there that my wife gave me the soda. My point is that I was not drunk! …I was hypoglycemic. I had been using these darn re-called infusion sets MMT-396, 397, 398, 399.

    The police had commented that I was resistant to their approach and they had considered hauling me away. I guess that in a country that is saturated with drug users, that is what they expect to see and then, seeing is believing. Talk about short sighted. When I have low sugar I am always resistant to anyone helping me. I feel vulnerable because I cannot think clearly. This may seem to be a fatal flaw in my psychology, but I truly feel vulnerable.

    My wife was asked to leave the conference by the company CFO and then based upon my actions he would be seeking her dismissal. Rude no dought, arrogant with certainty, but mostly just a stupid fool is my response to his action. We left that night and 10 hours later I had a grand meltdown by another major hypoglycemia. I was saved by my wife and Chocolate! I went through so many inserters that I was running out and had another week to spend in Europe. Seven more days with only 2 cannula, should normally be enough to get me home. Well nothing was normal about this trip.

    The batch of inserters I had taken to Europe had all been bad therefore I used the last one three days before coming home. Medtronic was contacted and they refused to send any infusion sets to Europe.

    My wife had flown to another U.S. city for business four days prior to me departing Europe. She was summoned to her company’s North American corporate head quarters several days later were she faced a review based upon my actions. Please note that this is an Irish international powerhouse that does not let women lead, it’s a man club, and they routinely throw parties that provide booze and faux gambling. I suppose they think everyone is a drunk. With-in a matter of days she was jobless based upon my actions and other political jive that had been fabricated.

    I currently have only MMT-397 infusion sets left and I believe that I can go to my supplier and pull the records of sets that were sent to me over the years. Then I could document the type of infusion sets I was using. I wonder if my wife and I can use this to prove our case against her previous employer …and yes a law suit has been filed by her against that company and now I wonder if I can file a suit too. I may be looking to hire counsel.

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