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Jesus. QA is not a corner you should cut when it’s literally life and death.
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.
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.
“and would be an apocalyptically huge lawsuit.”
Apocalyptically huge lawsuit, here we come!!!
This all vibes like the kind of lawsuit that ideally should land managers in prison.
So if I understand it, a bug has been identified that’s potentially going to make diabetics OD on insulin and die.
That’s fucked.
I quit Insulet (I was the principal software dev for Android on OP5) because management didn’t care about this kind of thing. I couldn’t stay in good confidence.
You should reach out to the dev in the post. Your experience is going to be very interesting to any lawyers he talks to.
I’m not going to X, but if anyone contacts me I’d certainly talk.
“But why would you do those steps in that order?” - The programmers, probably.
I’m wondering if the field where you input the insulin amount is the same as you input the carbs, as that’d easily explain the bug. Reuse of the same field without proper checks can easily lead to… “Funny” results. If the carbs and insulin fields are completely separate, then that’s some very weird math bug they’ve put in there, somehow.
Thanks to Bush II, medical device manufacturers are immune to class action lawsuits!
Yay Capitalism!
My Dad had the leads on his pacemaker fail and caused his heart to be repeatedly and continuously shocked.
Leads were replaced but guess who paid for that?
It wasn’t the manufacturer!
If your dad managed to torture the CEO, do you think a jury would convict?
Like honestly.
To be fair, prison treatment aside, the fact that the elderly don’t rob banks, confuses me greatly.
Guaranteed housing, meals, and health care.
Sure it’s prison, but what is an elder care home, but a prison. for the elderly?
Certain states have better prisons.
Use that social security check to travel to NY and not Texas or Florida.
A story from a type 1 diabetic:
I had what we will call “an incident” where I took pretty close to this scale of extra insulin. I’m a much heavier insulin user but it varies greatly between people and the kind of person who is dosing fractions of a unit like 0.15 turning into 15 would be a massive problem. It took about an hour for me to get to the hospital and I seemed just fine at that point. I don’t know why because usually the type of insulin I use hits it’s peak within an hour for me. My only guess is that my body was overwhelmed and somehow delayed my reaction to it, which I’ve never seen before.
I got into the ER and they were very casual about it. From my past experience in medicine I’m guessing they weren’t sure if it really happened and wanted to see how it played out. My blood sugar was somewhere around 100 when they first tested me. 5 minutes later it was in the 40s. At that point the nurse said “oh fuck!” and sprinted to grab D50 (basically a sugar infusion) from where they keep their meds. I have been a paramedic (not just an EMT) and I can count the number of times I’ve seen a nurse run on my fingers.
They started an IV in both arms and were pumping sugar in to keep me alive. My memory gets kinda hazy after that. They kept checking my blood for potassium levels because burning through that much insulin + glucose uses it up and can stop your heart. Eventually they had to start a central line (like an IV but straight into your heart) in my neck to deliver insulin because they were worried all the sugar they were giving in both arms would burn my arm veins. I remember the feeling when they started it and used a probe to see if it was in the right place the “tickling” feeling literally in my heart. I ended up in the ICU on 1-to-1 with a nurse because they had to monitor me so closely. If I had been later to the ER by 10-15 minutes I wouldn’t be telling you this story. I also had the benefit of knowing what happened ahead of time, which you would not if your pump magically multiplied your dose by 100 and you didn’t notice.
All this to say, this is pretty fucking serious.
This, right here, is why “professional” software “engineers” should be licensed.
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.
Official announcement from Insulet:
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.
It’s available in other regions as well.
- Select “Yes”, even if you aren’t from the US.
- Open the menu on the top right and select your region the bottom.
- Profit.
Super simple and intuitive. /s
FDA: we have rigorously tested the pump and have found no issues.
Public What about the app, which can control the pump and was written by the lowest bidder with no QA department?
FDA: We have no jurisdiction over phone apps, due to the legislation that gives us jurisdiction over pumps being from the 70s. I guess, just don’t use the app?
It’s wild because in a lot of cases the FDA does have jurisdiction over the apps, they just choose not to check them.
