[schiffern]

The user-blaming stands out in their official communication. Bad sign for company culture.

> Once the bolus dose is confirmed and you tap START, the value that is shown on the screen will be delivered by the system...

> As stated in our User Guide, it is important to review the bolus amount before you confirm and start the bolus. Omnipod 5 will always deliver the amount you confirm and that is shown on the Confirm Bolus screen (Figure 2).

Is this saying there's no way to stop it, even if it hasn't performed the injection and killed you yet?

"Hello, Insulet customer support? My Omnipod is going to kill me. Quick, what do I do?!?"

"Didn't you read our Guide?? Omnipod will always deliver the amount you confirmed! RTFM!! click"

--

Seriously though, what's the intended recovery procedure for this? Can the device be removed quickly? Batteries taken out? Emergency Stop?

Or are users expected to carry a firearm at all times to "rapidly disassemble" a murder-happy medical device? :-\

[jacquesm]

You can pop the pump off on a moment's notice (there is a needle sticking out of the pod at the back, some other manufacturers use an umbillical that can be disconnected).

Totally agreed on the communications failure here, they all but blame the user for not noticing their error. That's not how a responsible medical device manufacturer should deal with this.

[schiffern]

Thanks, good to know. That's something at least!

[jacquesm]

These wearable pumps, especially in combination with closed loop are a very interesting and important medical development that can improve quality of life for a huge number of people, but these sort of fuck-ups are really concerning. Inexcusable, especially because they have failed on multiple layers (code review, automated testing, acceptance testing, firmware development). Shocking, really and it makes me wonder wtf is going on at that company software development wise.

[mlsu]

On the flip side, what behavior would you prefer? The pump to not always deliver the amount you confirm?

I mean, this is clearly a bug, but under normal operation it would be much much worse if the system silently overrode a user dose. People's insulin sensitivity varies a lot. A 350lb person may regularly dose 10 units for a single meal, whereas that dose would kill a small child. If you are 350lbs, and your BG is 400, in DKA, and you're dosing 15 or 20u as a correction, you do not want an automatic early termination of the dose.

You can always cancel a bolus in progress. The override/cancel bolus is likely the highest priority task in the entire system. In the worst case, you can physically disconnect.

[schiffern]

> On the flip side, what behavior would you prefer?

Personally I want a (mandated) hardware Emergency Stop button, like any other machine with potential to malfunction dangerously.

A button needs protection from accidental activation, but fortunately that's a solved problem.

> You can always cancel a bolus in progress.

I sincerely hope that's true, but the documentation makes the intended behavior very unclear.

[peteradio]

In case of buggy interface behavior violently rip device from torso.