FUDiabetes

Medtronic certified pump trainer killed by own malfunctioning pump

RN / Medtronic certified pump trainer killed by their own malfunctioning insulin pump:

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Well, that’s it, I’m turning in my Omnipod. No more pumps for me, just too dangerous. Won’t get in a car anymore either. Or use the stove. Or use knives. Or get in the tub. And those stairs, boy oh boy, I guess I’m stuck inside my apartment for the rest of my life – which won’t be very long with so many dangers everywhere.

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If you would like to find other interesting cases you can just search the MAUDE database and see all of the adverse events that have been reported for every medical device in the US. I will say that if someone thinks that all of these reports of death are actually the fault of the device, I have some good stuff to sell you…

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm

I won’t comment on that poorly written hit piece, because there are so many things not said in it, like was her pump still attached, i.e. why would a thinking person keep a device attached to them that was known to be malfunctioning. etc. etc.

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I do think that pumps require quite a bit of training, more than MDI, which is simpler. They can create dangers, although I feel that the danger of forgetting that you already injected you basal insulin for the day for MDI is as significant as the dangers that accompany a pump (particularly, but not only, for older patients).

That said, I was disappointed by the quality of this article and of its analysis:

Insulin pumps linked to more reports of injury and death than any other medical device

  1. What jumped out at me first is that analysis they pursued did not calculate any ratio, such as deaths per number of user etc. That, in itself, seems to me a disqualifying factor for the soundness of the article.

  2. Few of the devices listed give much latitude to their users, if any: grafts, pacemakers, heart valves, of heart pumps.

  3. Some of the devices listed are typically only used by professionals: defibrillators

  4. None of them involve injecting a deadly poison, which, unfortunately, has to be done daily by all PWDs in one form or another.

her family now says it’s possible using a pump was never a good idea for her. They say she was a “brittle” diabetic, which means her blood sugar levels were unstable and sometimes reached extreme highs and lows. […] “She was … not even a candidate for the pump. I don’t know if anybody had mentioned that to her.”

That is really questionable, if not outright false.

  1. “Brittle” diabetes is not a recognized diagnosis any more, and its existence is in doubt:
  1. If there is one such thing as “brittle” diabetes, most teens have it. We, for instance, would deal with brittle diabetes: we hardly have a day without at least one “unexplained” (i.e. hormonal, of course) peak to 200 or much worse, requiring large amounts of insulin, and typically followed by bad lows. But, on the contrary, this is exactly why we need a pump—MDI is not giving us enough control. And, sure enough:

The first tool listed by Healthline to treat “brittle” diabetes is… an insulin pump.

  1. The family is suing Medtronic. So their claims may well be biased towards success in their court case.

The pump uses only rapid-acting insulin, which means the user can have worry-free meals and snacks at the touch of a button.

That sounds great! We’d love one of those! Oh wait, we have one already… The author is not well educated on diabetes in general, and on insulin in particular.

In the end, I find the article sensational and unconvincing. I really like the Canadian press, but CBC did a bad job, and I don’t think the Globe and Mail would have published it.

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The danger on MDI of confusing basal and bolus?

Like millions of people with diabetes around the world, Landry used an insulin infusion pump to try to improve her quality of life.

MILLIONS of people worldwide on insulin pumps? Really?

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During a severe hypoglycemic event the first thing that goes is your ability to make rational decisions and problem solve. Truth.

Of course that’s the obvious solution when you’re thinking clearly. When your blood sugar is ~<35 or so you aren’t capable of thinking clearly.

@Michel The point I’m trying to make here is that this person was a certified pump trainer! They’re the ones who were training others. It wasn’t some moron who didn’t know how to operate their pump.

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It is a good one.

Yet, if the poor woman was permanently disabled by a malfunctioning pump, it is one sample instance. The only conclusion we can draw is that people can get killed or permanently disabled by a damaged pump.

What would be useful to the debate, I think, would be to compare deaths or grave accidents due to a pump vs an MDI regimen. Unfortunately, I dont think that exists, because neither for a pump nor for MDI do people track the incidence of such incidents (hah, how do you like that?), when they are specifically related to the manner of administration.

For instance, when, a PWD is found dead in bed, how many times is the diagnosis tracking the exact cause of death beyond that? If it was an insulin overdose, what caused it? Was it an unfortunate combination of events? Alcohol ingestion? A hard sports practice followed by a heavy pizza meal (you know what I am alluding to I figure)? A accidental double basal injection for MDI? A dialing mistake on a pump? What about what causes all the cases of DKA for already diagnosed T1s? The only thing we know, because it is a stat whose tracking is required by the FDA, are the numbers of incidents due to a malfunctioning pump.

It would be great to know it all but I am pretty sure that none of those stats are available—although I would love to be wrong!

Yet this family claims she was misinformed :roll_eyes:

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Btw, @Beacher, your comment was quite evil :slight_smile: I had a good laugh despite trying not to!

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Here is another Associated Press release that covers the same stat:

This one is a better one, but leaves many questions unanswered—I think because the answers don’t exist.

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Just doing a quick casual search through the FDA Adverse Event Reporting System (FAERS) shows far more hits related to Insulin Pens as opposed to pumps.

But that is strictly a casual search without putting significant effort into it.

(Note - I am pretty good with big data.)

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I’m wondering if it was a 670g pump? Ok, kidding…

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So much information is missing. After reading both the CBC and the AP report, you still don’t know if the incidents happened due to pump malfunction or not.

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Exactly, when you start reading the reports that are being entered, you see a lot of stuff like this:

image

Not exactly earth shattering.

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Pumps are not dangerous if they are used correctly. MDI is not dangerous if it is used correctly. If they are incorrectly used, refer to Darwin’s law.

A dental professor gave me sage advice when I was in dental school. A student was having problems with making a procedure come out correctly on the bench. He asked why. The professor responded that “if you do it correctly, there should be no problem”. The longer I live the better I understand the veracity of his statement.

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Every time you call Omnipod when you have a failed pod, or any problem, sometime during the conversation the agent will ask if you had a medical problem as a result of the incident. I can’t quite remember the exact phrasing, which is obviously important—but, everytime your answer is positive, it will result in a filing such as this one.

If only 1% of the calls misunderstand exactly what is being asked…

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Besides the Novopen, most other insulin pens don’t seem to count as a device in CBC’s database. So that explains something.
Apart from that, what medical condition and medical device are actually comparable to diabetes and insulin pumps? We’re dealing with a highly variable disease that requires treatment with a deadly drug of which the dose constantly needs to be adjusted. How surprising is it really that a device designed to administer this drug ranks high in this list?

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One thing I’m curious about is if she was obviously out of it when she called the tech support line, do they have any power to tell her to hang up and call 911 or contact a family member or anything like that? I would feel terrible if I was that person on the other end of the phone and found out she died when I could tell something was wrong the night before.

Exactly. I can’t think of many other medications, or medical devices, that are as dangerous as insulin that aren’t dosed and monitored exclusively by doctors or nurses.

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The devil is often in the details.

Does driving on a highway count? That is pretty hazardous although I think the media chooses not to dwell on the tens of thousands of people killed in the US every year (directly involved with vehicles) and millions injured. Perhaps not as glamorous of a headline?

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Well, in general I would not regard that as a medical condition, but it is certainly dangerous :grin:

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