We have been using an insulin pump for seven years, not Medtronic but I have always had this concern. I have heard about the same situation happen with Omnipod. It makes you wonder if your son’s life can be possibly harmed by the same device that helps him stay healthy.
It is scary for sure. He should be seeking a lot more tha 75,000 damages.
This give good reason why we test 90 minutes after starting a new pod. From the article, she changed her infusion set and then went to bed.
I am not the biggest fan of Medtronic.
But I don’t believe this.
Not that I don’t believe somebody would file a lawsuit - that is entirely believable.
But I don’t believe that what is claimed in the lawsuit is reality. They claim the pump malfunctioned such that
… insulin pump had delivered up to an entire week’s worth of insulin at one time …
I flat out do not believe it.
@Tim35 Did you read further down, where it says the minimed infusion sets were recalled on November 18, 2017 and that the company began to warn physicians in September 2017.
I remember when that happened.
Those infusion recalls have zero chance of causing something like this. the two events are in no way related. Zero.
Edit: To clarify. This is certainly what the lawsuit is claiming. I am just saying no way. Per the lawsuit:
The Medtronic MiniMed infusion set at issue malfunctioned as a result of a defect that caused fluid to block the infusion set membrane during the priming/fill-tubing process, which prevents the infusion set from working properly and results in over-delivery of insulin.
ahh, thanks. The way I read it, it looked like a continuation (of the background story) of the original problem.
All of this is scary. I’ve always tried to change my pod early evening, so I had time for the 90 minutes test. Not sure now if 90 minutes would be all that is needed before there could be major problems as explained in the original link.
I don’t know what happened in this case but I do know that MedT sent me several snail mails about this issue. There must have been some issue that motivated them to address it. It had something to do with a fabric seal on the infusion set that mated with the insulin cartridge. If it got wet during the cartridge refill, it had the danger of over-infusing immediately after a cartridge refill.
I don’t comprehend the technical aspects but they went to a large expense to recall a lot of infusion sets. They were motivated by some requirement.
There is reference in article that Sure-T infusion set were used and that malfunction resulted in full weeks worth of insulin being delivered. This does not make sense, related to the recall, as I don’t think sure-t have the membrane. And delivering full cartridge of insulin would be more likely mechanical problem not infusion set, but unlikely.
First, don’t scare me, I just ordered an Omnipod trial. Second, the recall was due to people getting insulin on top of the vial when filling a cartridge and somehow some membrane was causing a pressure problem if it got wet. My understanding was it was all related to technique and that’s why they posted info/snail mail on that. Supposedly they redesigned things. But when I was looking at the MAUDE database, I did see numerous cases of insulin being dumped out. There were a lot and I didn’t even look very far. I was researching the 630g in 2017 and 2018. Yikes, I did not even research the pods!
This is the part that I have a really hard time believing also. I used an Omnipod for years, then switched to a MiniMed about 18 months ago, because Insulet, at the time, didn’t have a Medicare contract. In both cases, the delivery set is supposed to be changed every three days. Now, if the husband didn’t know this, and didn’t care to be informed about it, that would explain his misunderstanding, but I’m a little baffled as to why the reporting didn’t say something about that, or why Medtronic didn’t say something about it. Maybe they did, and I just didn’t see it. You can extend the delivery life of the MiniMed set somewhat by loading more insulin than you use in three days, but I don’t think the infusion set would last more than twice as long as it’s intended. Skin oils, soap and water would do a number on the adhesive. Omnipod doesn’t allow that flexibility. You have an 8 hour grace period after your first alarm to change the set; after that, it just stops delivering.
I’m not sure I understand. You can load the reservoir with as much insulin as it takes and keep using it until it is empty. When I pump I load up to 300 units and it lasts me almost a week. There is no requirement to change it every 3 days and even though it is contrary to Medtronic’s guidelines, there is no reason the pump should empty the reservoir into the user no matter how long it has been in the pump.
Sure. If you have a lower TDD and starting with a full cartridge, it is conceivable that one cartridge could contain a week worth of insulin for you. I assume this is likely not the most common case. But that aside.
I do not believe it is physically possible for any sort of infusion malfunction to cause an entire cartridge full of insulin to be pumped into a person.
This was what I always did when I was on a MiniMed pump too. You can change the infusion set and still keep the same reservoir over the course of a week (or however long the insulin lasts). For a week, this would result in an average TDD of about 43 units (300/7). I dose a little over 20 units a day with my basal insulin now, so 43 units sounds very reasonable. You’d have to change infusion sets of course because they don’t work as well after so many days and the scarring would be worse if you kept them in for that amount of time.
The story sounds like crap though. I don’t see how this sort of infusion malfunction could happen.
Remember, people who write up these stories probably dont get pumps very well. And to say a week’s worth in my case would be appropriate because I use one cartridge per week. We surely dont all do that.
The membrane warning may or may not have had to do with over delivery.
But as I said, the FDA MAUDE database has an awful lot of cases posted where this exact thing happened. And I only researched the 630 g…
On the other hand, I have absolutely no problem believing a lawyer would bring such a lawsuit. That seems entirely plausible to me.
Yes, with the MiniMed you can do that, if you don’t experience skin irritation or if the infusion set doesn’t come off, but the pump warns you at the end of three days that it’s time to change, and doesn’t give you another reminder until the reservoir runs out.
I got training from a CDE on using the MiniMed, and was told then not to go over three days before changing the infusion set. Do I do that sometimes because I can, and don’t want to waste any more of what’s in the reservoir than I have to? You betcha. Based on my prescribed dosage, Medicare considers two vials a 50 day supply. If I run out before 50 days, too bad.
I’m having a hard time wrapping my head around having a bolus of the entire reservoir, too. The facts as presented in the linked article include a lot of holes.
I checked the database and read details on several reports for Medtronic pumps. In all cases I read, it mentioned the person died while either using, or had been using insulin pump. Cause of death was NOT clearly identified as pump failure, and many reports listed heart failure, kidney failure, etc as contributing factors, some stating pump was removed prior to death. Reports often said pump was to be returned to manufacturer for analysis, but none that I read actually said they were returned and tested.
For the original posting, it’s possible the death was caused by overdose of insulin. But there is not enough detail to know that, and if user or pump malfunction or both were factors.
No, I saw a whole bunch that said the pump dumped the cartridge in the person’s body. But there were so many it felt like they may have been made up. And I do believe it did say they did not get the pump back but I cannot remember.
We’re talking using a cartridge or reservoir for a full week, not the infusion site tho.