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Medtronic Synchromed and MiniMed Pump Problems Draw FDA Warning

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The FDA has issued a warning letter to Medtronic Inc. about their Synchromed drug pump and MiniMed insulin pump, saying the company needs to fix deficiencies in quality control and reporting at a Puerto Rico plant that manufactures the medical devices.

The Medtronic warning letter lists a number of problems, including violations of federal regulations and good manufacturing practices at the facility, which were initially discovered during an inspection in late 2008.

The violations included failing to maintain process control procedures to make sure products conformed to their specifications, failing to ensure accurate records for each batch, lot or unit manufactured, failing to evaluate and investigate consumer complaints involving problems with the devices and failing to report problems where malfunctions could have resulted in serious injury or death.

The FDA notes in the letter that the individual problems it has found may be “symptomatic of serious problems in” Medtronic’s manufacturing and quality assurance procedures.

The letter criticizes the company for taking two years to recall the Synchromed II Pumps after the company discovered some models were missing a key propellant. The FDA letter states that Medtronic initially identified the problems with the pump in May 2006, but did not issue a recall or inform the FDA of the problem until May 2008. About 13,000 units were affected.

The FDA also noted several failures in Medtronic procedures that allowed the pumps with the missing propellant to go out, including the fact that a weight test indicating something was missing from the pumps was apparently ignored or overlooked. A lack of adequate device history records also allowed problems to slip through, the letter states.

Many of the problems also deal with failures in the facility’s reporting procedures and investigating complaints from consumers. The FDA alleges that Medtronic did not submit a consumer complaint regarding the MiniMed Paradigm Insulin Pump because the company determined that the malfunction being reported was unlikely to result in injury or death if it were to reoccur. However, the company had already reported several complaints on the exact same malfunction, having determined that those malfunctions could be life-threatening.

“The information in the complaint indicated that the user contacted your firm because the user had a blood glucose level of 456, and that the user’s MiniMed Paradigm Insulin Pump had failed to alarm when it stopped delivering insulin,” the warning letter states. “The user was subsequently hospitalized and diagnosed with diabetic ketoacidosis.”

The agency also criticized Medtronic for not having someone with the proper qualifications and training to make a medical judgment regarding the danger of device malfunctions. According to the FDA letter, Medtronic was employing a product reporting specialist for the insulin pump who only had a high school diploma and some “additional in-house training.”

Medtronic officials have stated that most of the problems at the Puerto Rico facility have been corrected since the FDA inspections, but the FDA has yet to determine if those corrections have been adequate.

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24 comments

  1. sara Reply

    my mother has been using the minimed paradigm insulin pump for some years. i always had faith in this product to save her life. till June 28th, 2009 my mother had suffered 4 broken ribs, brain bleed, and a stroke. on top of this i managed to take off her insulin pump after the hospital never removed it before doing a ct scan and a x-ray. after finding this out i removed her pump as quickly as i could. my mother spent 2 weeks in icu. the doctor had even told my family to be prepared to lose her within 72 hours. her blood sugars were going up and down so fast. 4 doctors later and weeks of holding our breath my mother healed. i have had her home for 2 days now. i recieved the recall the day my mother had been released. i immeditally checked the last package open amazingly lot 8. then i decided to further investigate and check out her daily totals of insulin on her meter (she is now on injections) to my horror i seen her daily total for that day was 86.65U her daily intake is to be no more then 30 units. as i kept looking i seen high amounts. my mother has been sorta in and out of confusion for 2 months no wonder why her numbers of insulin was huge. and on top of this her pump magically stopped workin for a week but no alarm. when i called minimed they told me it’s impossible for this recall to harm my mother or raise her numbers due to the fact that this particular sets where sent out 6 months ago and it only involved high altitude. that my mother had to manually have taken to much. i know my mother better then anyone and i can tell you she wouldn’t ever do that. i want answer’s and i want them soon. looking on the fda website this same issue seems to be repeating but it seems that some family members blow it off when someone of their statute says it’s not their fault. i called them for answers not a run around. how about the truth from them instead of the lies that this won’t happen again when as i said before it has. how many innocent familys must face what my family did before they realize that they need to fess up. i don’t want their money. i want them to admit that their product can kill. they took a part of my mother from my family. she don’t remember her grandchildren, she can’t fed herself, and only says yes or no. this is far from the lady who was once a emt, therepist, and dedicated mother/grandmother. this product has hurt more then just my mother. i’m just sure many won’t sit there and fight them but i can gaurentee you this family will till the day we die because my mother didn’t deserve to be harmed from their ignorance.

  2. naoual Reply

    i have been using the insulin pump for 3 years. since that my sugars were never controlled, either too high (500) or too low (25). One time i even had memory loss for 7hours , thanks god my husbund was at the house and he noticed that i forgot his name and even who he is, he called a neurologist in order to get a clue for what’s going on, the doctor knew that all about low blood sugar according to the symptoms, my husband check my sugar and gess what ;it was very low (21) he treated me whith glucose injection until i get fine. The problem was the pump that deliverd a lot of insulin that day because when i checked my sugar the night before it was (187)and the pump injects 3units of insulin . it should be fine if the pump was working properly.

  3. deborah Reply

    my aunt died on june 18th. someone just told me about this. the odd thing was first mini med told me she owned the pump and i could get a refund for $6k for it. when i called back to tell them I had the pump….they were wondering if i wanted to send it back to determine if it malfunctioned. I said, why would I want to do that,…NO ANSWER. I said, no I want the money owed, next thing this customer rep tells me, she did not own it, that they would send me a box to return it. I said, wait a minute, send me proof that she did not own it. I was told a manager would call me and the proof would be sent. It has been 3 weeks and no calls back as promised or proof sent by mail…..

    her docs all were surprised she died,….maybe they were right, she was having these huge blood sugar swings …and in fact was hospitalized for one of them about a month before she died. no one ever tried to see if her pump was malfunctioning. so now i am wondering, if she was a casualty of the mess up by mini med.

  4. deborah Reply

    it is me again, I found her 5/8/09 bill and it lists 20 quickset paradigm infusion sets batch # 8200955 MMT-398 which is the recalled batch.

    This very possibly could be the reason she died and considering the sneaky thing medtronic tried to pull on me……….re ownership…..and wanting to know the name of the person, I first talked to…..and then telling me that she did not document my first conversation. I am really beginning to wonder………about this entire situation.

  5. Jerry Reply

    Sara I was just reading your comments about how medtronic minimed only malfunctioned at high altitudes they lied to you mine malfunctioned when I was priming my pump.
    I hope your mom is getting better

  6. Tiffany Reply

    My stepmother was on the insulin pump for a number of years. She was one of the most well contolled diabetics. Sadly after 3 and 1/2 weeks in a hypoglycemic coma she has passed. Currently there is no answer except for the fact that her insulin pump worked the night before when she changed the insulin bottle. The next morning when the pump was inpected the bottle was empty. Normally this amount would last her for three days.

  7. C. J. Reply

    I have had a Synchro Med II Implanted since July 04. 3 Different doctors from 3 different locations recommended the implant for pain management over a 5 yr. period. I waited another year to have it implanted. It relieved more pain than any other treatment or oral opiates I had ever been on, but in May and again in June of 2006 I went through excruciating Morphine Withdrawal where my blood pressure went up to 240/190 and was taken to the ER at a local hospital. No one there knew how to manage the pump and they contacted the clinic where I regularly had the pump filled. None of the doctors at the clinic would show up at the ER. One of the nurse practitioners and doctors tried to convince me that I had jus gone thru “Electrolyte Imbalance”, but I knew better. So did the ER doctor and the EMT’s that took me to the hospital both times. They said it was Morphine Withdrawal. I ended up in the hospital a 2rd time in July and was evaluated by a Psych Nurse, because the Psychiatrist would never see the patients until 11 pm at night when they were all asleep. The psychiatrist asked the Pain doctor to write up an evaluation of what happened in May and June when I told him I had gone through Morphine Withdrawal. The Pain doctor said I had only gone through Electrolyte Imbalance, because the Reservoir of the Pump worked and there was still medication in the reservoir so I must have been “Over Reacting” when I said I had gone through Morphine Withdrawal. The Psychiatrist therefore misdiagnosed me being extremely bright but having a Borderline Personality. In Feb. 09 I ended up in the hospital again. It was during that time that a CT Scan was done of my spine and it was discovered that there is a fracture in the catheter of the device part that is in my spine against my spinal cord. I was so angry, because the doctors at that new clinic had done CT Scans of my spine in 2007 and I had asked the doctor to look at the CT Scan with me in June of 2007. He looked at it then, but neglected to discover that the fracture in the catheter had been there in the previous CT Scan done in 2007 and his belief is the fracture occurred in May of 2006 when it caused me to go through Morphine Withdrawal. At the time in May 2006 I was going through a divorce and too ill to represent myself in a protracted divorce trial. The divorce trial was set for 12 July and I had just gotten out of the hospital on 8 July 06. I requested the Judge post-pone the trial because I had just gotten out of the hospital and all day had layed down in the back of the court room. The Judge denied the continuence and gave all of the community property assets to my husband (including my house that I had paid for with my inheritance which was now gone). He stated “Let’s make sure she doesn’t get any community assets so she can qualify for SSI, but she probably doesn’t even HAVE a Morphine Pump”. He gave me 7 days to get out of my house. My ex-husband sold my house in CA. and bought a 40 acrea horse propertyy with the proceeds while I was forced to live in my car for 3 years. Now I find out that in 2006 when I went through Morphine Withdrawal is when the pump catheter most likely broke and that the Pump is now being recalled for a battery defect. This SUCKS BIG TIME.

  8. Rachel Reply

    I have been on my pump for almost 2 yrs. And it was great at first but over the last year I have had many problems where my inserter gets stuck in the insertion device because they are not properly shaped. Almost everytime I change my pump I have to trim the inserter. I also have had problems with water. I can only take a shower once every 3 days because I remove the pump and tubing and all but the minute the sticker part gets wet it falls off. Which also makes it so I can’t go swimming or anything to that effect either. I have also had the problem where somehow the canula got kinked under the skin but my pump did not warn me and didn’t know till my bloodsugars were through the roof. Earlier this summer they recalled Lot8 infusion sets. The only problem with that is it was 2 wks after I had used them. I don’t know it just seems medtronic has alot of problems and to me it seems they are not even trying to make any effort to improve or correct the problems.

  9. DEBBIE Reply

    I have had CRPS (complex regional pain syndrome) for more than 10 years. Since May 1999. It is in my right hand, arm, shoulder and neck and now on the left hand.

    I have had so many ganglin blocks and other types of injection I lost count. None of which gave any pain relief. I had a single and a dual lead spinal cord stimulator for 5 years which did absolutely nothing.

    Then I my doctor added the medtronix morphine infusium pump with combination of morphine, clonadine, and sufenta. My PPO insurance ran out and had to change to an HMO (Kaiser) which removed the two stimulators and removed ( against my pleading and begging) the sufente from my pump. At the time I have the 3 combined meds I had close to a 98% pain relief. I had an allergic reaction to the baclofen. Now with just the morphine and clonadine combination I only get 50% pain relief ( on bad days it feels like no relief at all).

    I have had very few problems with the syncro med I and 2 (the newer version) Twice the lab made a mistake in the mixture and I ended up in the hospital with total withdrawal. Other than that I have been very pleased with the pump. It’s been a blessing for me. before hand I litteraly lived in a recliner. (totally drugged with oral meds. I was ready to end my life if that was all there was to it. Nothing helped.
    I do not have too much to complain about. Just wish there was an approved formula for the sufenta . The only problem I have is the weight gain and the protrusion of the implant.

    The only symptoms I currently have is numbness in my right hand and arm and now 3 of my fingers on my left hand. Also some in my legs. also a problem with lack of circulation in both of my lower legs. My Dr. has yet to explain what is happening.

    My experience with this disease not many doctors know too much about this disease and every time you ask a question they look at you funny and never have an answer why. or even a speculation.

    All I can say to anyone who has this implant until something better comes along. This is as good as it gets. however bad it is there is nothing better for now.

    I have lost any kind of hope for a miracle cure for this disease. Just live day to day. And do the best i can to get through it. I thank God every day for the support of my family. With out them I don’t think I would be around today. Thanks for listening.
    I

  10. Shirl Reply

    I too did not have much trouble with the pump at first but now it seems like the quick set is always getting air into it and where there is air there is no insulin so I am short changed. I have tried to work with the company but it seems like what they tell me to do does not work.
    I have been a diabetic over 51 years and have never been in the hospital with it. As far as I know I have no major problems. I just want to keep it that way but I am really thinking of going back on shots. At least I know that I am gettin the insulin I need. I too had the lot 8 sets. My A1c was high during the time I was using them.
    Being a diabetic is hard enough without the problem of our pumps not working like they are suppose to.

  11. Mark Reply

    I have been on the Paradigm insulin pump now for two months. I too have had a lot of issues with the quicksets not working correctly. In particular the 6mm cannula often kinks preventing the delivery of insulin. What is more disturbing is on two ocasions my blood sugar rose over 450 due to a kink and not once did the mini med pump warn me of “No delivery”. It was after feeling lousy and testing my BG did I confirm the sky high results. I called the minimed on the first occasion and they had me perform some tests to confirm the pump was working correctly. After performing a serious of diagnostics, they told me to change my quickset. However, the pump should do a much better job at warning you anytime insulin is not being delivered. As well, Mini Med needs to substantially improve the quality and reliability of the quicksets and cannula. The unreliability of quick sets seems to be wide spread amongst users.

  12. Debi Reply

    I’ve been using a Medtronic MM pump for about 6 years now. Tonight, my pump stopped working (again). I’m going on my 5th pump in 6 years. The problem I’ve run into is condensation getting into the pump after I work out. All of the buttons stop working. I just got this replacement pump less than a year ago. Since my previous previous pump (yes, I meant 2 previous’) fell out of warranty 1 month before it went out, I had to purchase the new pump with a warranty – good thing, since it didn’t last a year. I hate shots. I love the pump. I just wish it was more reliable. After reading some of the stories here, now I’m a little worried it may kill me one night in my sleep. 🙁

  13. Mike Reply

    I had my Synchro-med II pump inplanted in December of 2007 and for the first 3 months it was a god send. Then in February of 2008 my catheter became disconnected and I stopped getting relief. My oral pain meds use had gone up drastically and I kept telling my Pain Doctor that something was wrong with the pump. His comment to me was ” I’ve been putting these pumps in for 15 years and I’ve never had a pump just stop working” are you sure your just not enjoying the extra Oxycodone” which needless to say infuriated me. After 6 months of upping the dosage on the pump, I think I was up to 7.4mg of Morphine a day (intrathecally of coarse) his nurse suggested that they do a patency test just to make sure it’s not disconnected. Low and behold the catheter was disconnected and another surgery later it was reconnected. After 2 more weeks I still was not getting the relief that I had gotten back in Feb. this time after a couple more months of complaining they checked the pump again and found out that the catheter had slipped out of the intrathecal space. So after surgery number 3 was done they discovered that there was a granuloma that had formed at the end of the catheter. Had i known all these problems with this pump, I would have never had it put in. That being said, now that my insurance has changed there are absolutely no Pain Management Clinics that will take me. It’s as if I have the plague. They say that it is too much of a liability risk, and I have to go back to the doctor that put it in. Unfortunately, he does not take my insurance. I can’t even find a doctor that will take the pump out. Does anyone out there have any ideas????

  14. Ali Reply

    I’ve been on the pump for over 1 year now. Last June starting having trouble with high sugars, was hospitalized for 3 days with very high sugars. The nurses didn’t know how to work the pump so they called the clinic and someone came to help me do it. When the cannula was pulled out it was bent in the shape of the number 7, I received no warning that I was not getting any insulin the days before the hospitalization. I thought I had the flu, so explains the high sugars. Had never had any problems before this so I didn’t know to change the canula, I only changed the tubing that when I checked was also not deilvering insulin either. By the time I made to the hospital my sugar would not register on the meter. I almost died. Infact the hospital staff told my partner to call all my family for I was not going to make it. Kidneys were shutting down, etc. I did infact make it & I’m pissed as hell. All I had to go through because of a bent canula. Has anyone recently had the same trouble. It’s been a year now & I appear to still be having some struggles. I’m seeing a therapist for major depression and PTSD. I just want to know if there’s anyone else out there that had the same trouble with the canula’s getting kinked or bent

  15. steve Reply

    I first started on the minimed pump shortly before the lot 8 recall. I was hospitalized twice in the short time i was on the pump. about a year or so. I kept getting the warning that there was no insulin delivery. after going through the checklist to try to figure out the problem (kinks in the tubing, infunsion leaking, etc.) it didnt fall into any of these catagories so like someone else commented medtronic just told me to switch the set. then five sets later one finally worked. Then one afternoon my bg was 56 so i had pizza for dinner and took insulin accordingly the next morning i started feeling nausea and was vomiting everything. thats when i said oh #$@%! I’ve had this feeling before. These were the symptoms of DKA. So after being out of the hospital a week I get the recall notice in the mail from my pump provider not medtronic. I didn’t get that till about a month later. Then about 8 months later i was having these symptoms again which was really bad because i was home alone with my then 10 month old daughter for the weekend. My bg’s were sky high (650’s) so i took 15 units of novalog which any diabetic knows that will lower your bg dramatically. So i checked my bg again an hour later 500’s something wasnt right so another 10 units i took, checked it an hour later back over 600. Fortunatley my child could tell something was wrong and did not leave my side and took a long nap till my wife got home and took me to the E.R. . Docotors were able to get my acid gap closed so they put back on the pump with an increased basal rate and low and behold i went back into DKA and got a nice room with a view in ICU. While there i was visited by a medtronic rep who tested my pump. He set it to give him a bolus of 15 units enough to soak his hand with insulin. A DROPLET came out and come to find out the pump had a malfuctioning piston delivering insulin. I asked to get that in writing from them. I’ve been waiting about a year now and nothing. Then medtronic wanted to send me a new pump. it was under warentee so i wouldn’t have to pay $6,000 for it just send the old one back. and when i told the im not sending the old one back they told me the new pump would be $3,000 . So i told them the hell with them and there $6,000 death box and have been back on injections ever since. After this stunt i did some research and learnd that this company as a whole is bad with pace makers and other items bing recalled. Now im staring to show signs of circulation problems that i shouldn’t be having, I’m only 27, which i feel is in result of this terrible product.

  16. Stewart Reply

    I had a Medtronic morphine pump installed in 2006 for severe lower back pain, resulting from 2 bad surgeries. The last year I have been experienceing Angina in the chest. After two Cardioligists checked me and performed every test in two hospitals, they concluded that it was the Morphine Pump, now they are turning it back every two weeks until it is comlpletely turned off. It will probably have to be removed.

  17. Jacqueline Reply

    I have been a diabetic for 29 years, I went on the minimed pump in July of 2010. During these 29 years prior to being on the pump, I never had a DKA reaction. Since being on the pump for only 7 months I have had 10 !!! I have also never had a severe hypoglycemic reaction where I was very disorientated, sweating profusely, minutes from passing out. when I got home (after eating a bag of sweet candy )My bg was26 !
    The pump has problems with insulin delivery more then working effectively. Most of those times are caused by a bent cannala! The pump does not alert you of “no delivery”, until hours later when your bg is through the roof ! When I phone medtronic, they often make it out to sound like most people do not have problems with their pump like I am. Then they make comments like” are you putting the infusion set in scar tissue”? I’ve been a diabetic a very long time I should know what the heck scar
    tissue is! I am really starting to think that this pump is doing me more harm then good! I just wonder why they can not come up with a much better type of cannala ? To me I wouldn’t think that it would be that hard to do.

  18. Lisa Reply

    I am trying to find out if there can be complications with the morphine pump if you were in a severe accident and the device took a direct blow under your abdomen? What happens if an airbag hit the device just right or if the device becomes undone from the IV Catheter? Does it continue to run and deliver lethal doses or can the device be punctured open and deliver lethal doses that way? I go to a pain clinic for chronic cancer pain and they are trying to get me to convert to the pain pump but I have done the trial and it didn’t work and I have fears of serious complications.

  19. Martin Reply

    Nn April 2nd, 2011, my wife had been having hallucunations, talking to people who weren’t there,seeing our dogs dancing in the fireplace, etc. This was the first time I had seen this behavior in 12 years of marraige, and I planned to take her in tiher (Kaiser Perm) doctor for evaluation. We had a good meal, she checked her blood sugar after her usual post-meal wait, and apparently was OK- the meter, as well as he Mini-med Paradigm will show time checked, as well as insuln baaal rate setting . She changed her set and refilled the unit, and went to bed about half an hour after having loaded a new cartridge and installing a new catheter. I came to bed around a half hour later, and noticeed that her breathing was very ragged and wheezy. I tried to wake her to put on her CPAP, but she wouldn’t wake. I tested her blood sugar and found it to be 29. 29!!!
    I called 911, the paramedics took her to the closest local hospital. When I arrived around 10 minutes later, she was still in a confused state, although she was awake. She had had 2 glycogen pens and a liter of dextrose, but they were having difficulty in stabilizing her blood presure, a problem which persisted after her ambulance transport to Kaiser-Permanente in Fontana CA. She was pumped full of IV liiquids, causing extreme bloating, or edema. She coded (coronary arrest) and was flatline for at least 8 minutes (and probably more)., this being the evening of the 17th. By the time I arrived at the hospital, she had been transferred to the ICU, which is where she should have been all along, as the floor above did not have telemetry linking her monitoring devices to the nurses station, which IS the case in the ICU. She had no pupillary reaction to light, and her pupils were fixed and dilated.
    She was examined by two neurologists, and also had an EEG. At 7:30 PM, her mother and I, upon the advise of the attending physician, authorized removal of her life support, as she (and I) specified in her advance directive.
    I believe that the extremely loow blood sugar, and resulting comatose state, was caused by a malfunction of her Mini-med Paradigm, as she had never had that low a blood sugar previously, and was extremely competant in the settings and reloading of her pump. I am holding both meter and pump for an independant evaluation as needed for litigation if I can find an attorney to take this case.
    When I got to the hospital

  20. amy Reply

    my 29 year old son died march 6th, 2011 due to a diabetic seizure. He had a auto accident 12/8/10 that casued him to lose his license, also do to low blood sugar. In February 2011 he had a low blood sugar and had a siezure even after treating it with food, the pump showed BS increasing and 15 minutes later he had a seizure. His girlfriend was with him then and called for help, and gave glucagon. We are looking into a problem with the pump, we are not sure why after not having problems for over a year this happened. He had a new pump in summer of 2010. Very healthy, no problems even after being a diabetic for 20 years. Has been on the pump since 2000 when he went to collage, played 4 years of football there! we already have an attorney so please do not contact me for legal reasons.

  21. MGP Reply

    The Medtronics Paradigm pump, which was forced upon us by Medtronics’ hostile takeover of Minimed, has now failed 3 times in 6 years (once mechanically and twice electronically, all internal failures), necessitating a new one each time. Somehow, Medtronics has managed to declare it “out of warranty” each time. The Minimed 508 pumps that were replaced by this Paradigm unit were flawless in performance: if they did not deliver, they told you so. Only one of those EVER failed in the 10 years we used them, and it was immediately, cheerfully replaced under their 5-year warranty after 4 years and 364 days of good operation.

    The Paradigm FREQUENTLY declares a complete delivery, when in fact no insulin has been delivered, which is obvious by simply looking at the luer graduation marks and measuring one’s blood glucose (even the wireless sensor Medtronics sells to go with the pump indicates the blood sugar is not being controlled while this is happening). The Minimed pump NEVER did this (it had an accurate feedback system inside): there is a serious flaw in the mechanical positional feedback mechanism of the Paradigm pump. I speak with some authority: I am a Controls Engineer of 40+ years’ experience designing things much like these pumps. In our experience, the Paradigm mechanism is a flawed design, and unreliable, considering its main purpose is 100% accurate drug delivery control, which is precisely where it fails.

  22. david Reply

    i have the medtrinic nini med repl 3 times in over a year twice the pump froze uo once one of the chips malfuntioned. they would not give me a answer they were hacing problems..i do not recommed the mini med

  23. Tim Reply

    I have had a Minimed insulin pump for over two years and have never had a problem with my pump. My sugars are in much better control. All Medtronic reps I have spoken with have been very helpful and have always been quick to resolve my problems(I lost a battery cover and ran out of insertion sets for example. They were so nice and took care of me right away. One episode happened on Christmas Eve). No I do not work for Medtronic. Just a big fan. They may have SAVED my life. I am sorry to anyone who suffered due to a malfunctioning pump but not every diabetic death is a result of a pump failure. And attorneys couldn’t give a crap about your loved ones. They only care about $$$$$$.

  24. Jenny Reply

    My son (6 years old) started on the Medtronic minimed Paradigm 751 their new break through technology. After one month the pump failed and was stuck in the” fill tubing” loop. I feared that the pump had given him a bolus of insulin while stuck in this mode but I was never able to retrieve the information because even after removing the battery the pump went directly back to the fill tubing mode. They shipped a new pump and all was well until today when my sons blood sugar was 54. We treated the hypoglycemia with juice and snacks. After treatment his blood sugar was still 64. When I checked his pump there were large air pockets in the tubing. I went to change the reservoir and tubing and the pump was stuck in the fill reservoir mode. I fear there are serious technical issues with they pump and I fear for the safety of my small child. I fear the pump gave him a bolus of insulin because there is no explanation for the low bolod sugars after treatment.

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