URGENT: Field Safety Notification from Insulet (makers of Omnipod)

Note from Insulet:

Dear Valued Insulet Customer,

Insulet Corporation, the manufacturer of the OmniPod Insulin Delivery System, is committed to keeping you and your healthcare professionals up-to-date in the event there are any issues that arise related to our products.

As part of our product quality monitoring process, we have identified that 15 lots of OmniPod which were distributed in the U.S. had a slight increase in the reported cases in which the Pod’s needle mechanism failed to deploy or there was a delay in the deployment of the needle mechanism. The reported incidence of this product issue in the affected lots is approximately 1%-2%. Once we recognized this, we corrected the manufacturing process and implemented additional inspection steps.

No serious injuries or deaths have been reported in patients using OmniPod devices from the affected lots.

Download this .pdf to read the rest of this notice, and see if you might be affected:Patient Communication (FINAL).pdf (129.5 KB)

Thanks for posting. I didn’t receive this notice, but I get my pods from Edgepark, so I’m not sure I get these types of communications like I should. I did not have any of the lots from the notice in August. I’ll check these numbers.

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Thanks, Emily! I’m off to check lot numbers…

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Thanks for posting this, Emily. Any word on if they are offering blanket replacements for the affected lots? I’ve had four pods fail from lot L41800 already, and wouldn’t be surprised if more fail before I’m done with this box. As it is now, I will just have to keep calling OmniPod to get them replaced one by one, I suppose!

Oy! That sounds like a real inconvenience, @markeeezy. I have not received any communication from Insulet about how they’re replacing the bad pods, although I assumed that if you have pods from the affected lot you can just return them all for replacement, without having to actually TEST every one of them. I’d try that.

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Yeah, that would definitely make sense. When I called to report the 3 that had failed as of a week ago, the customer service rep didn’t seem to be aware of the bad lots - or at least, she didn’t mention anything about it to me. Just went through the motions as if it were a regular pod failure. So maybe the information was also only recently released internally?

I can only imagine the hassle Insulet goes through when there’s a manufacturing error like this.

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The company reported earnings Thursday and announced a $7.7 million charge related to this issue. Management, which changed last year, has made customer satisfaction and retention a high priority, in addition to stepping up staff to gain new customers. If you have a subpar experience with customer service, let someone in the company know about it. They are serious about this initiative.

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