816
Lawsuit time 🇺🇸🦅
(lemmy.world)
Reminds me of the Therac-25 incident..
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this post was submitted on 04 Dec 2023
816 points (98.1% liked)
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Jesus. QA is not a corner you should cut when it's literally life and death.
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.
https://www.omnipod.com/fsn-11-2023
Yikes.
“and would be an apocalyptically huge lawsuit.”
Apocalyptically huge lawsuit, here we come!!!
This all vibes like the kind of lawsuit that ideally should land managers in prison.
That is a sacrifice I am willing to make!
I love their subtle attempt at shifting blame here.
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.
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.I mean they posted the steps to replicate it so it wouldn't take long to debunk that sort of thing as being fake.
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.
It's class III medical device software