Reminds me of the Therac-25 incident…
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.
“and would be an apocalyptically huge lawsuit.”
Apocalyptically huge lawsuit, here we come!!!
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.
There is a video demo of the bug later on the thread.
Some android devices have a combination .- key on the numeric input UI. This is a contentious enough design choice to have stackoverflow threads on it. That combo key style is what’s used by the device and version shown on the demo. It appears that the device is reading that combo key as - and discarding (or taking absolute value), and not as a leading decimal.
FDA requirements were the first thing that popped into my mind. Is it possible somehow these devices fall under different regulations than “medical devices”? I am only vaguely familiar with the applicable 21 CFR regs. This seems like a pretty gargantuan screw up since it could, I would think, kill people.
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.
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.
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.
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.
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?