• gravitas_deficiency@sh.itjust.works
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    1 year ago

    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.

    • xalo@lemm.ee
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      1 year 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.

      • Quetzalcutlass@lemmy.world
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        1 year ago

        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.