FUDiabetes

Medtronic recall: infusion sets

Medtronic recalls some infusion sets due to “potential over-delivery of insulin shortly after an infusion set change”:

REF and LOT numbers can be checked here:

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I checked my infusion sets boxes and… all of them are affected. Should I be worried now? I don’t think so.

About one in every two million infusion sets manufactured before April may be associated with the complication, which occurs when a membrane that’s used to release pressure from inside the pump gets wet and blocks the vents, said Francine Kaufman, chief medical officer of Medtronic’s diabetes group.

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Do you normally change infusion sets morning or evening?

Most often in the evening.

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How scary is this…a diabetics worst nightmare…relying on a pump to give you the insulin your body needs, and that pump kills you. Glad they’ve caught it…hope no one has died from this.

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Wow. My mom had a Medtronic intrathecal pump (to provide pain meds - she has bone cancer), and it was recalled due to a similar issue - it would malfunction and deliver either too little or too much pain medication. Someone actually died because of an overdose due to the malfunction.

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Hopefully you do that early evening rather than late!

I know it’s bad, but often I do it late :scream:

Same here… I have two boxes on the recall list, but a third is from a separate order and is fine.

I kind of wonder how they computed the 1 in 2 million statistic. It doesn’t seem like it could have come from a random sample because at that low rate they would need a massive sample size. If it is based on reported incidents there could be way more incidents that go unreported.

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I was wondering the same thing. The only idea that came up was that they knew what manufacturing process was at issue and were able to do statistical analysis of the process itself… Hard to believe.

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I checked my boxes and I have to send in 15 of them. :slightly_frowning_face:

I have a lot of extra ones that they keep sending to me. I actually told them to not send me any more until next year. So, at least this means I have enough good boxes to hold me over until I get the corrected new ones.

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When we had recalls like this, as soon as an issue is detected, they freeze the affected product shipments and do testing. Based on how the testing went they calculate the defect rate. Sometimes, the defect can be attributed to a person or a particular machine, in these cases they run a batch on that machine and estimate the rate.

My guess based on the recall type is that it was an out of spec part defect from one of their suppliers, and they went to the batches of parts from that manufacturer and did their own testing. It must have been just a few parts out of a very large pool of them that were out of spec. With that said, over delivery of a drug is a big problem, hence the recall.

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all of mine are on the recall list. they are sending me an emergency box which will (hopefully) arrive this monday. i am currently w/out ANY that are not defective, and tomorrow was my time to change out my set. i am just going to keep it in for the forth day, rather than go off the pump and take Lantus for 24 hours.

what a complete bummer. i am glad i didn’t toss out the letter from Medtronic (something i might typically do ). i read it and called customer service immediately.

Medtronic has the best Customer Service of just about any of these available. they are so accommodating, thorough, and kind and compassionate and patient. (did i praise them too much :wink: ???)

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All of mine are on the list too. Is the set you’re currently using on the list? If so, I’d change the set instead of keeping it run for a fourth day. It doesn’t make any difference; both are on the list. Just make sure you follow these steps.

just received notice of a recall of defective infusion sets. unfortunately for me, every set that i have is defective. if you have not received your letter from Medtronic, call their 800 # for customer service immediately and make certain that your infusion sets are not defective. if they are, they will be replaced asap (within a week of your call).

i believe that this explains why i am experiencing so many terrible low BGs. (that is part of the defect that these sets are having; an over delivery of insulin)

take action ASAP

Daisy Mae

There’s already another thread about the recall:

I doubt whether this issue can explain that. First of all, according to Bloomberg only 1 in every 2 million infusion sets is defect. Secondly, as explained by Medtronic, the problem only occurs in case the infusion set membrane gets wet, which hardly ever happens. I actually tried it. I put used tubing in a glass of water for 15 minutes and then connected it to a used reservoir. It didn’t make moving the plunger any harder.

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I just merged the 2 threads :slight_smile:

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thanks. i wrote mine right after i got off the phone with them and couldn’t wait to report it. i was so famicht that i didn’t even go to see the other post. call me silly :wink:

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The Medtronic letter I got in the mail explains you could keep using the potentially faulty infusion sets if you make sure there isn’t fluid on top of the reservoir. It would seem that this would be avoided by holding the transfer guard so the reservoir is on top of the vial when you pull it out.

The letter also clarifies the 1 in 2 million is from reports they have received of this happening so the true number is likely much higher.

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