Reminds me of the Therac-25 incident…

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Official announcement from Insulet:

https://www.omnipod.com/fsn-11-2023

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Life saving info, only available in the US.

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It’s available in other regions as well.

  1. Select “Yes”, even if you aren’t from the US.
  2. Open the menu on the top right and select your region the bottom.
  3. Profit.

Super simple and intuitive. /s

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It looks like the advisory/recall notice came out (depending on time zones) either before his posts or shortly thereafter.

Looks like the company has jumped on this right away as they should.

They have several non app solutions for bolus dosing. Looks like the app is new (iOS version isn’t even out yet) and they didn’t vet their consultants output adequately. Probably because this was some quick port that was outsourced and management didn’t pay attention because ‘requirements are the same’.

Super important in med device development to have adequate internal oversight of developers to ensure requirements are properly rigorously tested. Especially in a class III device like this

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