I’m sure those that need to know already do, but just in case…
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Thanks for posting this!
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Everyone using the Omnipod 5 probably saw this other notification too, Insulet sent out emails about similar sounding issues with the Omnipod 5 controller (though in the email they stated the issue wasn’t related.) We’ll see! Mine has been fine so far & I’ve had it for 5 months.
@Mariethm That’s been posted a couple of times, but thanks for the actual document link! I received an email from Insulet about the recall at least 3-4 weeks back, but haven’t heard anything since then. Has anyone here on FUD received a new PDM or further word from them?
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Well, I’ve answered my own question by searching on-line. Insulet has reported they hope to have all the Dash pdm’s replaced by June of 2023. Seems like a long time for a “critical” problem, but you look at the costs involved (even for a cheap old cell phone as a pdm) it makes for reasonable logic. I read there are over 286K Omnipod Dash users, figure there are a percentage not using anymore (say knock off 25% as a WAG) so figure 210K users at $10-15 each (cost of system and getting them mailed out)…that comes to about $2-3M, not to mention the logistics involved in testing a replacement, purchasing them, and getting them shipped. No small feat!
I’m still glad to be on Loop using my iPhone and not needing to rely on their PDM, but understand many must continue PDM use!
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Still wondering why it is such a problem for them to just get the iPhones approved. Would it cost them that much more than replacing all of these?!
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@Eric From the “users” view, I couldn’t agree more. From the Insulet/governmental view, I can’t help but think it has something to do with the “logic” of Medicare coverage and the bottom line income of Insulet. My understanding is Medicare makes decisions on coverage based on whether a PDM is in use to determine if a treatment is covered by Part B vs Part D (i.e. whether its considered durable medical equipment [DME] or a drug…I think it may come back to the wacko “whether its tubed or not” Medicare decision from years ago). If accurate, if Insulet goes the “phone” route, they run afoul of the DME route because a pump only lasts 3 days, so they fear customer’s going another route because Medicare coverage is lost and might loose all those $’s; where if they put the PDM in the box, then it can be claimed to be DME as the PDM lasts the Medicare requisite period of time (yes, the current recall does make this questionable).
In the end, it has nothing to do with the actual “logic” of the situation, i.e. is it a medical treatment and should it be covered. Rather, it’s an interpretation of the established rule set, definitions used by the rule set, the stream of money, and who is doing the paying. Something along the lines of, “Trust us, we’re from the government!”
Note: I have absolutely no evidence to support the above, just trying to apply the “logic” of purported information from Medicare and Insulet, though use of the term “logic” may be grotesquely incorrect! I seem to recall an instructor in a philosophy class asking, “Is there ‘Truth’ or is it all perception?” A yes answer gets very messy…
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Actually “Omnipod® is covered under Medicare Part D” quoted from their web site. I am one of those questioning whether i should stick with pods and my Part D copays vs. Tandem tubed pump under Part B with zero copay using a supplement plan. I also have no idea why Insulet can’t get their app to work with iPhones. Seems like it’s a business decision though because there should be no technical reasons preventing it. “Can’t means won’t” as my father used to say.
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Reviving this stream for another recall notice of O5 software: Insulet Corporation Recalls Omnipod 5 Android App due to a Software Error | FDA
Saw this on JDRF site and thought I’d post it here as well!
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Well done, Insulet QA team! What could possibly go wrong with this scenario?
0.2 units or 20 units? I mean, really, what’s the big deal?!?
Insulet Corporation is recalling the Omnipod 5 App for compatible Android smartphones due to a software error that occurs when the user enters a bolus amount less than 1 unit without putting a leading zero before the decimal point. Due to this error, when entering a bolus dose of insulin less than 1 unit, the SmartBolus calculator does not register the decimal point if it is the first character entered.
For example, if a user enters “.2” intending to request a 0.2 units insulin bolus, the app would not register the decimal point and would display 2 units as the requested insulin bolus instead. Or if a user enters ".20” units, the app could display 20 units as the requested insulin bolus instead. This failure to recognize the decimal point when entered without a leading zero may lead to the app giving too much insulin, anywhere from 10 times to up to 100 times the intended amount, if the user does not recognize the error on the calculator screen or the confirmation screen before confirming the dose.
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Really they didn’t do a .5 test? For me that is the most common correction that I do.
Really sad.
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Wow, I don’t use O5 but boy, sounds really dangerous. Thanks for posting!
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Oh my Heck! Does anyone that is using the android app here experienced this?
So when you just hit the bolus button and choose .20 and then hit the checkmark and then hit confirm it could just start delivering 20 units?
I would think the max bolus would stop this sort of error from occurring. Even if the system thought 20 units was appropriate max bolus should not allow the bolus to occur.
Dang! I would usually notice most of the time but there are instances where I’m driving and have a bit of a stubborn high and will quickly bolus .50 or so units at a stoplight (I know not a good idea). In that scenario I might not know until it was too late.
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I think it’s okay to do that. As long as you are stopped! 
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I use Loop, but same thing, I have never entered it as 0.xx units. I always hit the decimal first and then enter the units that come after the decimal. Every single time.
Here’s an idea, Insulet. Hire a couple diabetics to write your test cases for you!
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I don’t think ANYONE would hit 0.xx units! Unless it was in the training or something. I’ve been through Dash and OP5 training - no mention of that ever. I read both manuals as well and don’t remember anything like that.
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Except for the Insulet test engineers.
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I should have noted the recall appears to date back to November of 2023. Also, I have (edited to insert “no”) no interest in Insulet stock (that I’m aware of). Just thought this is a safety issue that I hope doesn’t hit anybody I know of here on FUD or elsewhere!
I’m with the rest of you, seems an issue that should have been discovered in testing and use by “real” people (i.e. not engineers, though no aspersion is intended toward a fine group of people, just that they may be more “detail oriented”). I bet it’s included in testing from now on! 
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