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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. S. Rounds Reply

    During the months of May and June 2009, I had started up my cycle of entering my summer car shows. I noticed that I was getting very high during these car shows (over 200-250), which was odd, as during prior shows I would tend to get low due to the energy I was expending preparing my show car at these events (waxing, polishing and buffing the car). Normally I would set a temp basal of 50-75% during show prep to avoid these lows (which worked fine during the 4-day January Sacramento Autorama car show (elevation of 200 ft., where I won 1st Place). But this spring things changed. I had to run my temp basal at 125% at an El Dorado Hills car show (elevation 1,200 feet) and 150% at a Rancho Cordova show (elevation 300 ft) and Maxwell show (elevation 500 ft). At the time, I attributed these weird high basals to the high temperatures at these events (near- or over-100 degrees). I started wearing my Minimed Paradigm pump in an insulated Blackberry PDA case (Minimed offers no such insulated case for pumps), but noticed that the insulated case had no effect on my high-temperature-low-elevation blood-sugar levels.

    I contacted the manufacturers of my insulin (Apidra) and notified them that I wanted to return my insulin, as heat, I thought, was evidently causing the partial failure of my insulin. They told me that they had never heard of this problem before, and that they would like me to send the insulin back to them. This contact with the manufacturer happened a week before July 4th. They told me to wait for the receipt from them of special insulated RMA shipping containers, so on July 4th I had still not returned the insulin to them. Note that I was normally not having a problem with my blood-sugar levels (my prior A1c test was 6.9). I live at an elevation of 3,000 ft., on a mountainside.

    On July 4th, I went down to Fry’s Electronics in Sacramento (200 ft. elevation) to buy some electronics. I noticed that my blood sugar went up at the store, and took some extra insulin to accommodate my high blood sugar levels (it was hot again that day). I noticed that I was trending slightly down in blood sugar after being at the store for about 2 hours (my glucometer said 75), but I was ready to head home to cooler temperatures, so I ingested 4 Glucotabs, an unusually large amount, as I wanted to be especially careful not to get low while I was driving (two Glucotabs normally raises my blood-sugar at least 25 points, so four should have raised me from 75 to 125-175). I waited 20 minutes in the store, noticed that my glucometer was indicating a blood sugar rise (it was up to 85) and then headed back up the hill towards home in Camino.

    When I got to Placerville (about 1.3 hours later) at an elevation of 2,100 ft., 5 miles and a 1,000 ft. down the hill from home, I was so low that I had no cognizance of my low blood sugar. My CGM was set to alarm at 75, but I dropped so fast that I was completely unaware of its alarming. At a curve in the local freeway, Highway 50, my car (a 2007 Mazda RX-8) drifted left from the fast lane and sideswiped the concrete center divider. The left-front and left-rear wheels were bent, the car’s left hubs (where the wheels attach to the car) were bent, and various other suspension parts were stressed/bent. The left side of the car had minor scrape marks on the front and rear wheel wells and front and rear mud flaps, all the way through the paint to the underlying ABS. Fortunately, only the bumper panels were involved (i.e., the front of the front wheel well, and the back of the rear wheel well).

    Oblivious to the car damage (I do remember, but just barely, hitting the center divider), I did not pull over to inspect for damage (remember that this is a new car for me, which I scrupulously maintain, and that I’m a real car guy), and I continued up the hill towards home. Other drivers on the highway called 911 to report my erratic driving. I drove right past the off-ramp for my house (at 3,000 ft.), and was continuing up the hill towards South Lake Tahoe. At an elevation of 4,000 ft. (Pollock Pines), the CHP managed to get me to stop. I was driving erratically in the slow lane at a speed of 10 mph. The paramedics, who were called to assist me by the CHP, reported a blood sugar of 30 on their glucometer. They gave me something intravenously, which brought my blood sugar up rapidly. They wanted to take me to the hospital, because “extreme lows can cause brain damage”, but I refused, had the CHP call my wife, and she came and picked me up.

    At this point, I received the first letter from Minimed explaining the “Lot 8 catheter problem”. I checked my partially used box of catheters, and the catheters were lot-8 and had the recalled letter code sequences on them. I immediately realized that the problem wasn’t high heat deactivating my Apidra insulin, but the fact that the high heat was always (in my case) accompanied by a lowering of elevation. I live halfway up the Sierras, and am constantly driving up-and-down through elevation changes of 2,000-7,000 feet. If only I had been told of the defective catheters earlier! I did not return the insulin to the manufacturer, and started using the replacement catheters sent to me by Minimed. I have done some traveling from my 3,000 ft. elevation to Sacramento (100 ft.) and to North Lake Tahoe (7,000 ft.), and have noticed that my unusual high and low blood sugar readings have now been eliminated while using the lot-8-replacement catheters sent by Minimed.

  2. Donald Reply

    My 14 year old son missed 50+ days of school last year and we took him to the Dr. several times during this period. All based on irratic bgl numbers and keytones. The amount of school missed forced the schoold district to threaten use of the Becka Law which can prosecute a parent for allowing too many absenses.

    My son suffered from sever headaches and stomac aches.

    If there is to be a suit I will participate. Otherwise I am going to approach sueing on an individual basis

  3. David Reply

    I need to start this when I first noticed the problem on November 17 2008 late at night I asked someone to drive me to the emer room because of low blood sugars ,there they made me it more got it back up and sent me home I woke up with parmedics the next day so off again they did the same feed me pie this time they told me again to eat more I wasn’t going through this again so I set my alarm for 2am a ate a peanut butter and jelly,thats the last I remember my doctor called medtronic and told them my pump malfunctioned they blew that off and said that I said that I had a ekg with my pump on All my doctors know I am on the pump and when I called them they wanted me to mail the old pump within 3 days or I would be charged $5000.00 I talked to someone else and he took all the information down but come to find out it never was sent,so here I am with the lot 8 thing . I had to go do the same thing again and made sure that he sent it . I told him also you blew it off about my pump malfunctioned what about the 8 boxes of lot 8 quick sets I have . I got a letter back from them and they said I sorry I had a problem with there products. I had one lawyer drop the case because no long term ingury . I guess if the pump tries to kill you 3 days in a row thats OK, I also had one say it would have been better if it did for my family

  4. Susan Reply

    I have had similiar episodes as the ones posted. I have contacted Minimed in regards to No Deliverys on my pump several times, and constant highs and lows that were unexplainable. The frustrating part of this is keeping my blood sugars in control because I am still using the lot 8’s. Minimed won’t send me my new supply order because they frankly don’t have any to send. They keep advising me to stop using the lot 8’s but they can come up with every excuse in the book not to ship my supplies except for the truth that they don’t have any! So in the meantime I am taking my life in my hands and hoping and praying that the worse thing that will happen to me is that my sugars will be a little out of control. HA! Do they realize the damage on my body that this will cause for the out of control sugars.
    There was another posting about a malfunctioning pump…I also had a similiar situation where they stated that my pump was malfunctioning and little over a month and a half later I received the voluntary recall notice. Voluntary? If it was voluntary then why are they advising everyone who calls in to stop using the lot 8’s? It’s not voluntary, they are unsafe and they are risking people’s lives …but not doing anything about it.
    My family deserves to know that I am going to wake up in the morning and not have a fatal car accident due to an insulin overage.
    I truly hope that there are attorneys out there that can stand up for all of these families that have lost time off work, have excessive medical bills, gone through serious injuries, trauma from worrying about using lot 8’s to keep yourself alive, and for those families may God Bless them and those family members they have lost.

    I truly want to be apart of this lawsuit against Medtronic Minimed!

  5. Patrick Reply

    I have had the same problems as well….i also have addissons disease and i was fighting dehydration several times a week b/c my sugars were so so high!!
    we need a class action suit. NOW!!

  6. Laurie Reply

    My boyfriend, was wearing an insulin pump the night he died. He also was using the lot 8 infusion set. Unfortunately we didnt know this at the time.. My guess is that he got low and never woke up. Not sure now what can be done. Will have to be looked in to.

  7. Richie Reply

    I was having massive problems at first trying to get my blood sugars low. I changed my infusion site numerous times with mostly bad results. I had bad episodes of lows and if your are a diabetic you can understand waking up in a sweat at three am!! Bottom line is I sorry that I switched from Animas to Medtronics. Well sent back at their request 12 boxes from lot eight, believe this i am still waiting for my replacements. My experience with them has all been bad. They need big fines imposed on them. The sales team are liars and cheats. Tricked me into switching to them from Animas what creeps. I have had nothing but problems since.

  8. Arleta Reply

    I have been hospitalized four days (3 of those in ICU) suffering from DKA and dehydration. Everything else including heart disease, kidney problems and much more followed and I am still recovering. I know my condition was due to the use of 8″ recalled Medtronic infusion sets, but don’t seem to find an attorny who will take my case. I was explained “Bush signing one of his lates laws while in administration prevents such claims on defective products. I need to know any lawyer who will take my case. I have accumulated significant medical bills as a result of that.

  9. Veronica and Bob Reply

    Our son, Bobby, battled with low blood sugars for months, we had paramedics at our house in December, a blood sugar of 26 after we found him. The lows at work were so bad that our younger son had a meeting to teach all the co-workers to use Glucagon. On May 23, 2009 he was killed while riding his motorcycle, no doubt due to a low, since he had eaten and would have bolused. After 8 years as a endocrinology nurse, I still did not suspect the tubing. I had him decrease the insulin amounts across the board twice. This young man, our beautiful son, is dead at the age of 24 years, 9 months, and 3 days, because low paid, unskilled labor makes a product that determined the health of my son. We are so angry. We too got the recall a few weeks after his death, and found his sets, which were indeed in the listed lot numbers. We definitely want to be part of a suit. That Mini-med would take this so lightly, even the CEO stating that no problems have been noted with this, is reprehensible. They should be held accountable. They would not be so cavalier if they lost a child. We want to know what we can do to join in this suit. THEY MUST BE HELD ACCOUNTABLE!!

  10. Doug Reply

    I have been a diabetic for 45 years and on a insulin pump for 10 years. I have never had to call a paramedic for low sugar. On May 14, 2009, at work, my sugar dropped to 24. If it weren’t for a coworker I could have died. I had problems with low sugar several times before this problem. I had 12 boxes of infusion sets starting with 8. If a class action law suit is started I will join.

  11. jamie Reply

    I am furious back in 2008 I started getting really sick my blood sugars were out of control .Then i started getting a no delivery option with my Insulin pump i was using lot eight infusion sets . Minimeds told me it was because i had developed scar tissue and the tubing was being bent on insertion. Well here i am now with now with the sure T insertion wich have metal needles instead of plastic ones and getting the same problem a year later . To top it all off i was never made aware of this recall.

  12. Vicki Reply

    OMG!!! I thought I was the only one that went to the hospital with DKA. I have had diabetes for 40 years. It does not take much to make me unstable. Thank God I knew what to do. After spending all day with high bs, I was going home to get insulin and syringes to start treatment on my own. I almost did not make it as far as the emergency room. After spending 9 hours with a BS highter than 600 and getting vertually no treatment. I finanally left the hospital and went home to take large shots of insulin via syringe. I never did get my bs back to stable until I started using Lantus again. I use 2/3 of my total background insulin of Lantus and the rest on the pump where I can watch it closely. I am afraid to rely solely on the pump. I still have two boxes of the bad infusion sets. If there is a lawsuit count me in.

  13. Howard Reply

    I suffered a near death low blood sugr on 9/1 2007. Went to the hospital and was in ICU for six days; then three months of brain damage rehab. I have permanent brain damage from the damage.

  14. Angie Reply

    I was hospitalized too for DKA and am having no luck finding an attorney. If anyone has found an attorney to represent them, please let me know.

  15. Roy Reply

    400s 500s 600s. Eventually I was setting alarm clocks to wake me every two hours. I changed infusion sets 2 and three times a day.
    I finally got a recall notice and a box of replacements and then ZIP. Did Medtronics close up shop or just forget to send the rest of the replacements?

  16. r.b. Reply

    My wife was a diabetic for 24 yrs. She got on the pump a couple of years ago and it worked well for quite a while, untill she got the “Lot 8 Quick sets”.She,(we) could not keep her blood suger in control and no one could figure it out.We had to test every two hours and I had to stop working because I thought that maybe she was doing something wrong or was’nt doing her blood sugers on time. It was hell !!! In and out of the hospital, no sleep, gloucose gel every other day,shots a couple of times a week or Boluses. When I saw that we were doing every thing right, but the blood sugers were all over the place I got suspicios.I even told my wife that if it kepet up much longer that she sholuld stop useing the pump untill the diabetis center figured it out. I thought maybe it was the insulin, but the insulin was’nt out dated and we keeped it refrigurated. On the 18th of June we had,had a few days of highs and my wife said she had had enough and wanted to go the hospital,(she never liked going to the hospital) so I knew it was bad. She collapsed in the driveway and I had to call an ambulance. The hospital got her on an insulin drip and got the sugers down.On the 20th the doctor said if she went on the pump over night and everything looked good, that she could go homethat next day. I talked to her that night and she was excited to be able to get back home. On the 21st at about 7:30 am I recieved a call from a nurse at the hospital.She said my wife had,had a low blood suger and that they had to give her 2 shots of D-50/60 ??,(glucose) to bring her back up. I knew that was very bad because that is alot of glucouse. So, I asked what her blood suger was when they had last checked it and she told me 9.Then I asked how often they had been doing blood sugers and then she said that she did’nt know because she was’nt actually on that floor ,that she had just been asked to call me. We,(her family and I) still ca’nt get an answer other than,”it was checked according to the orders”. So, we asked to see all the records.After not getting anywhere with the doctors face to face. We requested the records in writting. We got a detailed discription up to the date of the 19th. But we ca’nt get the direct orders, or the record sheets for the glucose tests from the 20, 21st. So, I know ther is somethig there. I got the pump while she was in I.C.U. and I found out that she had,had some highs on the 20th and that she Bolused for them. But there was no record after 9:45pm. So, if she had some highs that evening she should have been check often. For her sugar to go down to 9 they must not have been checking it verry often or else they would have been able to catch it in time. She recieved severe brain damage and never came out of the coma.The doctors said there was no chance of her ever becomeing consciuos. I knew she did’nt want to stay on life support as a veggie. So, we pulled the plug.She died on the 9th of July,2009 at the age of 38.Now, after seeing all the recalls for Med-Tronic devises I have become verry angry. Who,(gov.) or what agency is overlooking these companies and products ????? How many people have to die or allmost die before someone will do something. These med. companies have to be held to a higher standard and if it takes longer to get a product out on the market due to testing or finding , “Qaulified” personel than
    so be it. I am ,”lawyering up and gooing for blood”. Now I know that nothing significant will come of all this, but I have to do something. No one will lose there job or be prossicuted, I know that. So, the only thing to do is hit them in the wallet,and hopefully my children can get an education and have a better life.

  17. Kelley Reply

    We returned 5 boxes to Medtronic and was told that we would have to pay for another 5 boxes before we would be given our 5 boxes of replacements. To date, we have not been given any replacements, but have been billed for every new shipment received. Is anyone else having this problem. I wrote on my last bill that I was reporting them to the attorney general, but have not pursued that yet.

  18. Alison Reply

    I have been diabetic for 25 years (I am only 27 years old). I started using an insulin pump about 2 or 3 years ago. I have never been hospitalized for DKA in the 25 years until the lot 8 recall. I was using a lot 8 and spent the day in the hospital. The long term effects are imeasurable and I have sever paranioa about my pump. When I entered the hospital I told them I thought the pump infusion set may have been crinkled, and that was what was documented. A week later I got the recall notice. Because I told the hospital I thought the pump tubing was crinkled, that was the cause the hospital wrote down a lawyer dismissed my case.

  19. Janie G Reply

    My daughter, who was 8 years old at the time, began having very high blood sugar. We gave her extra insulin and when she didn’t respond, we changed her infusion set because we thought there were issues with absorption in the site. Over the next few hours her blood sugar soared and she began vomitting. I gave her a shot of short acting Novolog and water to drink and monitored her. She came down a bit but began climbing again. I then switched her infusion set again- this time with an infusion set from a different box. Her blood sugar became normal over a few hours after that.
    I went to the endocrinologist’s office shortly that and told her what happened and mentioned the recall of the Lot 8 infusion sets (I had gotten an email) and she seemed unaware of it.
    I always think that I could have lost her that day had I not thought to switch to a different box or if the new box was Lot 8 as well.
    I have never trusted infusion sets from Minimed ever since and have recently switched to shots and taken her off the pump.

  20. Carolyn Reply

    Today is Feb. 22, 2011..I have just heard about this…no communication from Minimed at all about the faulty infusion sets. Granted we had just moved to a new address in Canada on July 1/09, our mail was forwarded to our new address for 6 months. The e-mail addresses I provided to Minimed never changed and are still current. I am absolutely shocked at this very, very sad and tragic mistake this company has made. My heart goes out to all of you people affected by this.
    I have been on a pump for 12 years now and have been very pro-pump….not as much anymore. This makes me very wary. After we moved I had problems finding the Paradigm Silhouettes and had to settle for a box of Quicksets until they could order the Silhouettes in. Not even the pharmacy said anything to me. Maybe it wasn’t the stress of my move that through my bloodsugars all out of wack. Before too long the Silhouettes came in and I switched back over to them, and everything settled down after that.
    I am furious that no one from Minimed attempted to inform me of this recall….one of the reps knew I was moving and that my e-mail was staying the same, yet no word. Very shoddy.

  21. Ash Reply

    I recieved my pump from medtronic in 2007. I am a type 1 diabetic going on 20yrs. I first saw a problem with my pump AUG 2008 when i was hospitalized for a 900 bloodsugar. a rep from medtronic came to lok at my pump, reset it and said everything was fie. but it wasn’t. January 2009 I was found on the bedroom floor cold as ice. When medics arrived they couldn’t tell what was going on and my bloodsugar would not register. When I woke up from aweek long cma, the Dr. told me that I had a bloodsugar of 1906 and that I should have been dead. Out of all his years of practice he has never seen that and the person lived. Yes i survived a bloodsugar of 1906, but in the process was paralyezed from the neck down. After being in the hospital two weeks came three ad a half months of rehab.I had lost my abilityto do anything ncluding bath, feeding myself and walking. This was January 09, I revcieved papers from Medtronic in October 09 stating the issue wth the tubing and also i noticed the fact that the pump will act normal and sometimes not give you the alarm that say’s NO DELIVERY when its not giving insulin. I am just happy to be among the living and have my independance back along wih a new insulin pumthat works grat!

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