Insulin Pump Recalls — How Worried Should We Be?

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Here’s something I don’t like: the idea that a piece of technology I rely on to keep me alive could somehow kill me. I’m speaking not of Toyotas, but of insulin pumps — according to this piece in the Wall Street Journal, “the Food and Drug Administration said Wednesday it has seen an increasing number of hardware and software problems with insulin pumps, tiny devices worn by thousands of diabetics to deliver insulin.” And so on Friday, the FDA brought together an advisory panel of outside medical experts to discuss what actions might be taken to “‘minimize risks associated with the devices in these recall situations.'”

As someone whose pump once suffered a “button error” and began spraying insulin into the air like a fountain (or, less poetically, a peeing dog) I’m glad to hear that pump problems are something people are paying attention to. But I’m also curious as to what kind of issues they’re talking about. According to the Journal,

Manufacturers are required to report problems potentially associated with devices to the FDA. The FDA conducted a review of insulin pump-related adverse-event reports and found nearly 17,000 reports from Oct. 1, 2006, through Sept. 30, 2009. The reports don’t necessarily mean a device caused a problem but serve as a signal for more investigation. Even if a device is functioning properly patients can inadvertently misuse the device. Of the reports, about 12,000 reported a patient injury (such as problems with blood glucose levels) and 310 deaths.

The agency said the information provided by manufacturers involving deaths “was typically incomplete.” The agency said in 225 of the deaths reported the device problem was listed as “unknown,” although in many cases the device was never returned to the manufacturer for additional follow-up.

However, in 41 death reports, a device problem wasn’t identified but the circumstances involving the death involved diabetic coma and problems associated with blood-sugar levels being too high or too low, suggesting the device may not have been working properly.

So, uh, what are we supposed to conclude? Is the problem the devices, or the people using them?

I think it’s very important to keep track of these reports — since this is a situation where a product failure could kill someone, I want the companies who make insulin pumps to feel like there’s a fire under their ass. But at the same time, one of the reasons we don’t yet have a closed loop system (i.e. artificial pancreas) is because companies and the FDA are worried that the devices (or people using them) could make mistakes. Which, granted, they probably would — the question is whether those mistakes would be more severe and dangerous than the mistakes people with diabetes make every single day when we try to gauge interactions between insulin, exercise and meals.

I guess this is what I’m saying: it’s hard to draw conclusions from this article about how often the insulin pumps themselves are the problem (and how concerned we users should be about possible recalls). Looking at it on a more global scale, though, I have two competing desires. First,  for companies to pay close attention to product flaws that might kill people. At the same time, I don’t want an obsession with technical perfection — in the case of an artificial pancreas —  to get in the way of progress.

Bonus: Reading materials for the FDA conference yesterday

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JessicaSandy SawatzkyPete NufferJack FlynnJim Huck Recent comment authors
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Jessica
Jessica

I know this is a year and a half old. I just wanted to share my Cozmo experience. We had 7 ICU visits in a 3 month period. The last visit, I was on the phone with the pump company, and the rep was a Cozmo user. She told me to add up how much insulin has been delivered. Cozmo hold 300 u. I still has 20u left in the cartridge. When it was added up, it said it had delivered almost 400 units. This was right before the recall. This ICU visit resulted in my daughter coming off the… Read more »

Sandy Sawatzky
Sandy Sawatzky

Hi, I have been using a cozmo pump for about 4 years.  Twice I have had to have the pump replaced during this time.  The first time was no big deal.  The second time I had a seisure and went into a coma.  It was traumatic to say the least.  We waited for approximately a year to get an inconclusive response.  I was going to go off the pump at that time but my DR told me that there was more trouble with the N insulin than the pump.  My warranty has just expired and there is no way that… Read more »

Pete Nuffer

I’d be very interested in hearing statistically how these numbers play out (ie out of the number of pumps in use, what percentage experienced a failure of some kind?).  Having just put my two year old on the pump today and having a very frightening low only two hours into it as a result of bad insulin resistance ratio planning on her endo team’s part (and admittadly, my mistaken assumption that I should shut up and let the pro’s handle the calculations, even though I KNEW it didn’t jive), hardware malfunction is scary, but the human element is equally frightening,… Read more »

Jack Flynn
Jack Flynn

I have been using a Disetronic  H-Tron  (now an Accu-Check Sprit) Insulin Pump for nine plus years and have  had only one failure that could not be corected with a diagnostic restart that is performed by the user.  I used the back-up pump that is supplied by Accu-Chek until a replacement pump arrived the next day via FEDX.  This pump is reliable, rugged and compact and Accu-Check’s Tech Support Group is always on the ball.  I tested three other pumps before selecting the Disetronic, after 31 years of injecting, and remain happy with the decision. 

Jim Huck

This is a complicated issue, and I have a sense that there is some lack of transparency on the part of the insulin pump companies.
It totally freaks me out that you had a malfunction on your pump that caused to to pee like a dog.  That’s horrible.  Can I ask what brand it was?
I’ve been asking myself recently whether I should go back to injections.  I love my pump, but I’m pretty sure I could control things just as effectively without it.
Great post!

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