Reminds me of the Therac-25 incident…

10 points

That reminds me of that one Hacknet contract

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188 points

Jesus. QA is not a corner you should cut when it’s literally life and death.

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51 points
*

So uh… as someone who works in biotech and understands exactly what level of rigor is required before the FDA allows you to sell a medical device - a term that has specific legal definition, regulations, and restrictions, I’m a bit suspicious this could be fake. This sort of error would indicate a systemic error and abrogation of due diligence at at least 4 different levels, and would be an apocalyptically huge lawsuit.

Edit: I stand corrected - lots of people are corroborating this whole thing. That’s kind of astounding, tbh.

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25 points

There is a video demo of the bug later on the thread.

Some android devices have a combination .- key on the numeric input UI. This is a contentious enough design choice to have stackoverflow threads on it. That combo key style is what’s used by the device and version shown on the demo. It appears that the device is reading that combo key as - and discarding (or taking absolute value), and not as a leading decimal.

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65 points
47 points

“and would be an apocalyptically huge lawsuit.”

Apocalyptically huge lawsuit, here we come!!!

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14 points

If the user does not recognize the issue, this may lead to delivery of more insulin than intended

I love their subtle attempt at shifting blame here.

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8 points

FDA requirements were the first thing that popped into my mind. Is it possible somehow these devices fall under different regulations than “medical devices”? I am only vaguely familiar with the applicable 21 CFR regs. This seems like a pretty gargantuan screw up since it could, I would think, kill people.

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6 points

It’s class III medical device software

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55 points

Not fake. I’m a type 1 diabetic on this version of Omnipod and have noticed this before as well as other issues. I also had the app refuse to let me close an innocuous error modal window to activate a pod while I was in another country.

While I love the hardware, the software feels precisely like it has been outsourced to a team with no knowledge of what T1 is and whoever internally is greenlighting the changes isn’t properly testing.

The newest officially supported phone is the S21.

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24 points

I mean they posted the steps to replicate it so it wouldn’t take long to debunk that sort of thing as being fake.

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36 points

Sounds like the FDA should be involved here somehow…

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57 points

Christ Almighty this is the dystopian software future that my college computer science ethics professor was working so hard to delay.

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11 points

The dystopian part is when they’ll require you to pay a subscription to give you proper insulin dosages.

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30 points

part of the reason why the pharmaceutical industry is pretty rough and requires several verifications, as it only takes one mistake to be a fatal one.

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27 points

Any time someone bitches about government oversight and regulations, I think about cases just like this. In many cases we should WANT a large bureaucracy with plenty of checks and approvals overseeing things like this.

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4 points

Except the large bureaucracy must be honest in that case, otherwise it just starts exploiting lack of transparency to do nothing and get benefits for that

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Software Gore

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