Software Gore

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.

You should reach out to the dev in the post. Your experience is going to be very interesting to any lawyers he talks to.

Am a medic. Had a similar call, but dude ended up having a rare tumor on his pancreas called and insulinoma. They produce and hold a bunch of insulin and can occasionally rupture and flood your system with insulin. Ofcourse we didn't Know he had one at the time.

We had a non Diabetic PT that we found with a glucose that just read low. So 30< with our glucometers. Dumped 100 of d20 into him with absolutely no changes. Ended up infusing 4 more bags of d20 into him during transport. Got him up to like 80 and then watched him become unresponsive again 5 min later. Checked again and found it to be back to 40. He was in a room a few min later. Normally Im glad we don't cary d50 anymore that shit was like using a sledge hammer to hammer in a tack nail. But this was the one time d20 wasn't cutting it.

Anyways, glad you are alive. Shit can be scary.

It's wild because in a lot of cases the FDA does have jurisdiction over the apps, they just choose not to check them.

Former healthcare to software engineer working on a master's here. My colleagues who were licensed back in healthcare weren't all of the same quality. They all made mistakes at one point or another, some pretty bad some minor. There's no difference though, minor could just as well become major.

The way they get around it in healthcare is by throwing more people at the problem. You have a physician who is good at pointing in the general direction of the problem and a solution, then you have all the auxiliary staff who will narrow down on the solution based on their field. But at any single point all of them could fuck up, or one of them could.

Now that I'm a software engineer and I've written enough code to do stuff. I can confidently say that licensing will not solve this problem. Especially if there aren't enough people involved. Which is probably what was missed in the beginning.

Anyway long rant over.

Never gonna happen as long as the demand is so much higher than the supply.

Perhaps it should be a requirement for certain things though, like the medical area.

The dystopian part is when they'll require you to pay a subscription to give you proper insulin dosages.

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

Life saving info, only available in the US.

Wow, what a shit website. It just led to a neverending sequence of confirmation boxes untill I refreshed the page enough that it let me through.

Any time someone bitches about government oversight and regulations, I think about cases just like this. In many cases we should WANT a large bureaucracy with plenty of checks and approvals overseeing things like this.

Usually something in the testing process, or perhaps the testing process itself is lacking. For medical applications it should be pretty rigorous as the consequences if something slips through can be very bad.

If this is a new feature, then every step of the process designed to make sure it works failed. Which those are precisely will depend on the project, it could mean that multiple devs and QA had a look and either missed it or didn't think to test for it. Where I work the developer implementing a feature tests it, then 2 other developers review the code, one of them also tests it, then it goes to dedicated QA who will test it more in depth and also do regression tests (checking that existing functionality still works). The testing QA member also checks with another QA member about anything they may have missed in their test steps. But this can vary heavily, also depending on the general model of development cycle (agile or waterfall) etc - though I'm working on much less critical software, no ones going to get injured even if nothing works correctly.

If the bug was introduced through an update to this or another feature, their regression tests might be lacking.

It's also possible (though imo extremely negligient for such an application) that they don't have dedicated QA in the first place, and even don't require their devs to test comprehensively in place of dedicated QA.

Or, they found the bug, but management didn't want to allocate the resources to fix it.

Imo something like this slipping through shows negligience of some form, it's impossible to guarantee bug-free software, but this is not some obscure, hard to reproduce error.