FDA Recalls Defective iOS App That Injured Over 200 Insulin Pump Users (theverge.com) 20
Jess Weatherbed reports via The Verge: At least 224 people with diabetes have reported injuries linked to a defective iOS app that caused their insulin pumps to shut down prematurely, according to the US Food and Drug Administration (FDA). On Wednesday, the agency announced that California-based medical device manufacturer Tandem Diabetes Care has issued a recall for version 2.7 of the iOS t:connect mobile app, which is used in conjunction with the company's t:slim X2 insulin pump. Specifically, the recall relates to a software issue that can cause the app to repeatedly crash and relaunch, resulting in the pump's battery being drained by excessive Bluetooth communication.
This battery drain can cause the pump to shut down "earlier than typically expected" according to Tandem, though the pump will notify users of an imminent shutdown via an alarm and low-power alert. The company has notified customers to update the mobile app to version 2.7.1 or later, which should fix the defective software. While no physical recall is taking place, the FDA has identified this as a "Class I" recall -- the most serious type, as it relates to issues with products that can potentially cause serious injuries or death. No deaths linked to the issues have been reported as of April 15th. Tandem is encouraging pump users to take particular care when they sleep as it's easier to miss battery depletion warnings, and is asking impacted customers to confirm they have been notified of the recall via this online form. For any other questions or concerns about the insulin pump recall, customers should contact Tandem Diabetes Care directly.
This battery drain can cause the pump to shut down "earlier than typically expected" according to Tandem, though the pump will notify users of an imminent shutdown via an alarm and low-power alert. The company has notified customers to update the mobile app to version 2.7.1 or later, which should fix the defective software. While no physical recall is taking place, the FDA has identified this as a "Class I" recall -- the most serious type, as it relates to issues with products that can potentially cause serious injuries or death. No deaths linked to the issues have been reported as of April 15th. Tandem is encouraging pump users to take particular care when they sleep as it's easier to miss battery depletion warnings, and is asking impacted customers to confirm they have been notified of the recall via this online form. For any other questions or concerns about the insulin pump recall, customers should contact Tandem Diabetes Care directly.
I Guess... (Score:1)
...the user did not hold it the wrong way after all? /s
Seriously ... when people's lives can be endangered, getting it right must always come before making a buck off of it.
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Seriously ... when people's lives can be endangered, getting it right must always come before making a buck off of it.
LOL, since when?!?!?
Seriously when someone can go to school for the better part of a decade to be called a certified expert in a field that still calls it “practicing”, getting it right has pretty much always comes with time and experience, not merely tenacity.
Greed in capitalism hardly allows for that time and experience in development, in favor of chasing the shiny IPO penny.
Evaluated as safety critical (Score:3)
I'm guessing that the part of this that runs on the phone and iOS itself were not required to be evaluated as safety critical. Maybe they should have been.
It's hard to imagine trusting something so important to a program that runs on a consumer phone with a consumer OS and that communicates over bluetooth.
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It's hard to imagine trusting something so important to a program that runs on a consumer phone with a consumer OS and that communicates over bluetooth.
At first I thought this was an app that simply provided remote monitoring and data collection, then I read the description in the App Store. The very first feature listed is "freedom to deliver a bolus from your smartphone." That's a small injection of insulin typically delivered at mealtime from what I've read.
While the particular bug caused the pump battery to run down due to the repeated wireless communication, what if the bug triggered repeated insulin injection?
I'm surprised that such a feature is ev
Re: (Score:3, Informative)
Your suggested scenario is highly unlikely to be possible. The problem here wasn't erroneous signalling. It was the fact that app kept restarting and getting pump to go into search mode and pair with the phone again and again. Which is what runs down the battery. And even then, the pump itself has fail safes as noted, and warned user that its battery is low. So used can get their backup injector and do it manually.
Something that pretty much every diabetic who needs insulin injections has done countless time
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Re:Evaluated as safety critical (Score:4, Interesting)
Presumably the pump has safeguards for that.
The pump can work without the app - the app just provides an easier to use interface. There's nothing inherently safety critical to the app - if the app decides "user asked for bolus" then the pump will push once and then have a backoff timer - you need to protect against app malfunction as well as user malfunction (the user might be spamming the button multiple times - a very common event).
Chances are, there were no safety concerns because well, the pump protects against them - the user is just as likely to spam the button on the pump as it would on the app, so there's no concern there of a bug causing the app to continuously request extra shots.
The problem was, the app crashed, which had a secondary side effect no one really considered - that is, it caused the pump to use more power since its Bluetooth connection was being used a lot more. This had the side effect of extra battery drain and instead of lasting a day between charges, it might last say, 12 hours.
This can trigger a recall because if the user expected to get through the day without needing to charge their pump, they probably weren't counting on it dying midway through. Probably took a fair amount of investigation as to why the battery life on the pump was suddenly going from good to horrible.
That's why the phone isn't safety-critical. It didn't need to. it was just that an external device accidentally had bad effects on the battery life of the device
Re:Evaluated as safety critical (Score:4, Interesting)
It's hard to imagine trusting something so important to a program that runs on a consumer phone with a consumer OS and that communicates over bluetooth.
Gonna be even harder to imagine the look on your face when you peel the FDA-certified sticker off the $5000 medical version “approved” by your insurance company, and find a Windows Mobile sticker under it.
You’d be surprised as how “trusting” the alternative is.
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The screenshot of the app shows a UI for adding a bolus from the App itself.
I would say that seems pretty darned safety-critical that the App can signal the thing to deliver more medicine.
But also; the Pump itself ought to have a safeguard against needed power capacity for the expected runtime being taken up by the radio. I don't know what that would be... Maybe detect if the battery capacity is getting close to a level where it won't be enough for the remaining runtime, then power down the radio ear
Re: Evaluated as safety critical (Score:1)
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Typically, an evaluation of a safety critical system would include a fault tree analysis or similar. They might have uncovered this issue ahead of time had the thing been evaluated.
To Little, To Late (Score:2)
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The word you are looking for is "too".
Device that your life may depend on vs. "App" (Score:2, Informative)
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This app was written by the company that builds the pump it's connecting to. They already have access to all that data, and more.
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Re: Device that your life may depend on vs. "App" (Score:1)
Iâ(TM)m an expert on this topic. If you have (Score:2)
Re: Iâ(TM)m an expert on this topic. If you (Score:1)
Re: Iâ(TM)m an expert on this topic. If you (Score:1)