Insulin Pump-Associated Adverse Events: A Qualitative Descriptive Study of Clinical Consequences and Potential Root Causes

Type 1 and LADA
1

A very interesting report with comparative data.
https://www.liebertpub.com/doi/10.1089/dia.2022.0498

It shows the relative numbers of users of each pump, seems to show that Tandem pumps are more prone to user error, and are slightly less likely to have reported adverse effects.

Also that pump users under-report “adverse effects”.

I’m guessing that except for ER visits and hospitalizations many become accustomed to handling less severe things and have lowered expectations.

imo, that’s a problem. The more that competent and well-informed people complain, appropriately and effectively, about expensive equipment that doesn’t always work as described, the more likely and quickly that we will see improvements.

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@pstud123 are you a subscriber to liebert publications? I am glad to be able to read more than a synopsis of the paper. I checked on the subscription cost but it was out of this retiree on a fixed incomes range.

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I’m a retiree also . The article is free access (you can scroll through it and read or print it if you wish to using an incognio web session. ) It has a few errors I caught in the table statistics but is overall ok.

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I was able to read it off the link, thank you for the information. I do wonder one thing. Why was the Medt 630g and 670g pumps used with no mention of the 770g. This is a 2023 article. But it seems terribly out of date.

The number of reports for MedT reflects a product near the end of its life cycle. However, we do not know where the Tslim was in its life cycle since we do not get a notion of software version.

I think the comparison might be useful as the number of people who report issues, instead of the hardware being reported.

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I don’t think reporting adverse effects is going to happen soon. Except when you don’t have a choice because of an emergency visit.

I’m never going to report what I absolutely don’t have to. Sure I call in pod failures and my endo knows I am prone to them… but that’s the extent I probably would consider reporting. I report anything more major to her, I would possibly lose access to all sorts of things.

Examples;
You are having drops using a pump, the endo becomes liable knowing and might not decide to keep prescribing me a pump or something else I want.
Or I report something happened and the DMV finds out, a doctor reports it or someone does else that knows and takes my license.
I report to the pump company that I keep repeatedly hitting the wrong buttons on your pump and they decide their liability is at risk for me to keep using it.
I report to the insulin company that this happens sometimes when I use your pen or insulin and the insulin company says, hey you need to switch insulins.

We don’t want the liability that we know about now.

So not only is it a liability issue for the different people involved, but it’s also I might not get what I want to use and have it taken away from me. So why on earth would most of us chance that?

However complaining about something is far different than reporting adverse events.

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6

What if you could report anonymously?

7

Same!

Insulet asks if the pod failure affected my blood sugar.

No, of course not! I had no pod for a certain length of time while putting on my new pod, but somehow my blood sugar remained exactly the same as if I had continued to have basal insulin delivered! Craziest thing!

And they ask what my blood sugar was.

Gosh, I never tested it. Sorry!

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8

It never occurred to me that encouraging people to voluntarily participate in improving their own lives and the lives of others who share their disease through civic action would be a subject for debate.

I was raised to believe that if knew of a problem, a defect, but did nothing about it and allowed other people to suffer as a consequence, I became part of that problem.

Others here may not agree with that worldview, but I firmly believe that encouraging people to not participate in solving problems is destructive. We’re seeing the consequences of “it’s not my problem” on a scale previously unheard of.

If people here are not clear on what an adverse effect is, an adverse effect is anything that could produce a negative effect on health with the most serious requiring emergency treatment.

What the FDA is interested in is whether anything that it has a responsibility for regulating, including medical devices used by consumers, has any characteristics that makes them unreliable or unsafe for that application. If adverse effects aren’t reported the FDA doesn’t know that there’s a problem.

Adverse effects have causes. If they aren’t reported those causes aren’t addressed. it doesn’t matter whether they are due to operator errors, bad device interfaces, alerts that are confusing or not audible, difficulty in using a device, inaccuracy or unreliability.

If anything about a device you used could have predictably threatened your health, whether a medically necessary device failed and a replacement was not unavailable, if you needed or you only avoided hospitalization by taking emergency measures yourself, it should be reported.

If it happened to you, it’s going to happen to somebody else and they might not be as competent or lucky in dealing with that situation as you were.

The FDA does not forward information on the identity of a person filing a report to physicians or care providers and the form that’s used can make your identity anonymous to the company that makes the device.

You won’t get credit for it and you won’t get blamed for it. If it seems like too much work then I don’t know what to say. I believe it’s a small cost to live in a civilization.

https://www.accessdata.fda.gov/scripts/medwatch/index.cfm

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The article stated that it used the pumps that were available as of August 2020 and I think the 770g came out in October 2020.

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I guess I do not get the issue. I have reported issues in the past, without any problems.

11

Thank you, I just bookmarked that. It’s always good to know the right place to complain.

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I just found a 2019 media report that has some interesting observations and numbers. Apparently PWD are reporting more issues with medical devices than any other group. Four of the top ten most commonly reported device complaints were related to diabetes devices: BGMS, insulin pumps, CGMs and “artificial pancreases” - augmented insulin infusion systems.

Some medical devices more dangerous than previously thought
The TV report mistakenly said breast implants were number three when the listing they published had insulin pumps as #3 with twice the reported adverse effects.

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The reason may be the people using medical diabetes devices are more conscientious than those who are not. I tend to take these kind of statistical “studies” (in quotes on purpose) with more that a bit of salt.

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14

very few people use a self dosing dangerous drug, using our own judgement, the dosing can be modified, and it uses devices repeatedly. I would have been shocked if PWD’s were not the top five reported negative outcomes.

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15

I’m sure there are also many “adverse events” from syringe and pen injections that are not recorded.

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16

One would have to think that severe outcomes are just inherent with insulin.

17

I agree. Insulin is a dangerous drug people die from insulin overdose every day. I’m sure very few medications have a track record like that

18

Severe outcomes are possible with insulin. Severe outcomes are guaranteed without it.

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19

Social research methodology: How we ask the question frames the answer.

It sounds like if there is an adverse effect that they blame the make of pump. I am a user of Tandem (10 years) but my experience is it does what I tell to do. I have a lot of criticism for Tandem around ergonomics and usability but it is still a dumb pump designed by dumb engineers. I am shocked in 10 years no significant improvements have been made. Very weak blue tooth, small pump is good but small screen is bad. The weak link in the system is the Dexcom G6. I have to calibrate it once a day and I don’t get good readings first 36 hours. I have 5 instances of G6 reading 83-85 when I do a finger prick and it reads on the 40s! Is the pump to blame? My last A1C was 5.5 a week ago.

Sorry for the rant. I do wonder how the profit motive can overcome good sense.

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are there stats you’ve seen for that? I’m just curious as to the actual numbers