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Lawsuit time 🇺🇸🦅 (lemmy.world)
submitted 2 years ago* (last edited 2 years ago) by [M] to c/softwaregore@lemmy.world
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Reminds me of the Therac-25 incident..

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[–] 193 points 2 years ago (1 child)

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

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  • [–] 55 points 2 years ago* (last edited 2 years ago) (5 children)

    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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  • [–] 67 points 2 years ago (2 children)
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  • [–] 50 points 2 years ago (1 child)

    “and would be an apocalyptically huge lawsuit.”

    Apocalyptically huge lawsuit, here we come!!!

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  • [–] 56 points 2 years ago

    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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  • [–] 27 points 2 years ago

    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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  • [–] 9 points 2 years ago (1 child)

    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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