I recently did a writeup [1] on the 510(k) FDA clearance process (which cleared this device for market).
Basically this device was cleared through a DAG of other devices that were "substantially equivalent". I made a website to visualize these relationships, and any recalls that occurred in the parent devices. If anyone is curious about this particular device, see here [2]
[1] https://wcedmisten.fyi/post/medical-device-analysis/
[2] https://www.510k.fyi/devices/?id=K232380 (click on "Predicate ancestry graph")
I reported a bug with LibreLink to Abbott about 18 months ago and they still haven't fixed it.
The app doesn't respect Android's Do Not Disturb override list which essentially means I can't use DND on my phone. It's been the same on two phones, there are loads of reports on the Play Store reviews and on Reddit, so it's definitely a bug and not just me.
They haven't even acknowledged it's a bug, every time I'm directed to reinstall the app, clear the cache, factory reset the phone etc.
Kind of surprises me that something this easy to replicate and this pervasive (200+ instances is a lot of instances when you consider the size of the user pool) got through the testing. Would be interested to see what the FDA makes them do as corrective action and a breakdown of how this got into production code.
Talk about good timing: I switched from the Tandem to the Omnipod before this recall, but after Omnipod's own software recall had been resolved
https://www.fda.gov/medical-devices/medical-device-recalls/i...
At least the Tandem doesn't require using the phone app; it's not an option with the Omnipod, which has no other way of communicating with the device. (you either use an app on a small handful of approved Android phones, or use a stripped down Android device they provide you; iOS approval is in the works, but not here yet)
Apple already has tons of custom rules for different types of applications. Does anyone know which restrictions they impose on medical apps? especially ones that control medical grade devices?
The tech is really hit or miss sometimes. I have a pump that used to panic error out on a misused bluetooth connection, forcing you to set it up again.
Eventually the app developers fixed it but, for something that’s supposed to run 24/7/365 without fail it really rubbed me the wrong way.
On a slightly tangential note, I am interested in working on something better although not hardware inclined, so please reach out to me at my username @tutamail.com if you are interested.
I was personally affected by this, but it did not harm me. The battery drain was obnoxiously high (having to charge 2x a day instead of once every 2-3 days). I am always near a power plug so I was never in much danger of shutdown. However, I can easily imagine how others would be.
I ended up realizing something was odd with the app and tried uninstalling/reinstalling the app to fix it. Which did in fact fix it (at least temporarily).
"Battery low", "blood sugar too low" and "blood sugar too high" all sound like warnings that should be acknowledged by the user within 5 minutes, and if not the device automatically calls an emergency contact or emergency services...
Is that not the case?
Well, yeah. Controlling things with an app may seem like a sensible and efficient design given that the user already has a phone, but it seems outrageous to pull a whole phone's worth of complexity into the problem from a safety or security engineering standpoint. I'm genuinely surprised they're allowed to do things this way. Next you'll tell me the autopilot on a 737 runs as an app on the pilot's personal phone. The entire prospect seems to me approximately that crazy.
Just another piece of critical infrastructure or technology that’s suffering enshittification.
Bureaucratic capture ensures that any technology produced in a regulated environment requires a large organization to produce it, ensuring the extension of the bureaucracy into that organization as well and killing off any contribution from people who care. Institutionalized apathy is slowly destroying our world.
I wonder to what extent formal verification methods are being employed in the development of these kinds of things.
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I use a Dexcom Continuous Blood Glucose Monitor that pairs with this pump (I don't use the pump). And honestly, this is not surprising. The software quality in this space seems really low. I don't understand why some single-developer Mastodon client app can absolutely reliably get notifications to my watch but Dexcom can't. Even on the phone, the app cannot get alerts right at all, sometimes stacking them over an hour or more, but getting the current value for the alert, so you can get like five in a row (ALERT YOUR BLOOD SUGAR IS IN RANGE).
It's kinda terrifying to be honest.