Insulet recall

I’m sure those that need to know already do, but just in case…

https://www.fda.gov/medical-devices/medical-device-recalls/insulet-recalls-omnipod-dash-insulin-management-systems-personal-diabetes-manager-pdm-risk-battery?utm_medium=email&utm_source=govdelivery

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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.

Medicare | Omnipod HCP

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