Friday, July 10, 2009

Medtronic Quick-set Recall

A package left by UPS had me wondering what I won on ebay and had forgotten about -- until I noticed the return label from Medtronic, Betsey's pump supply manufacturer.
Inside was a fresh box of Quick-set Infusion sets that Betsey uses with her pump and a notice informing us of a voluntary recall on all Quick-sets with the Lot # beginning with an 8.


"The situation is related to the tubing connector. Approximately 2% of the affected infusion sets (which represents approx. 60,000 infusion sets out of an estimated 3 million infusion sets with customers) may not allow the insulin pump to vent properly. Venting is necessary to equalize the pressure in the reservoir compartment with the surrounding atmosphere. If the vent does not work properly, this could potentially result in too much or too little insulin being delivered and may lead to serious injury or death."

I frantically opened Betsey's hutch and looked through the basket we keep the Quick-sets in. Sure enough--every one of them marked Lot 8, and 3 more unopened boxes also with Lot 8. We have a total of 5+ boxes of Quick-sets with a recall, and probably went through 3 months supply of more!At Betsey's last clinic appt. her nurse suggested a problem with the sites because Betsey's numbers were fluctuating, and sure, it could be puberty, but in her experience perhaps it was a bad site, and maybe there was an issue with the sites she was using. She suggested I call Medtronic and make them aware of it.
I can't call myself dumb, nor foolish or ignorant, but maybe uneducated about this, and also lack of experience, because I did not call Medtronic. I figured, this too shall pass. And left it at that. We had had so many problems with Betsey's last insulin pump and the infusion sets we used-terrible situations leading to kinks in the tubing so delivery would stop - overnight - sometimes having to change the site daily because it would just clog or get tired fast. They were awful. So this new pump and the infusion sets were a dream because there is virtually no problems or complications. Maybe I chose to hang onto that.
In any event---here we are, a recall, and the nurse was right!

I have to send all these recalled sets back to them and they will in turn send out new boxes.

Is this the explanation to Betsey's uncontrolled fluctuating sugars in the last 3 months? Was it all because of the crazy sites not working properly? Or was it just a phase, a growth spurt? We'll never know, that's the thing. because even if we start using the new sites, and her numbers even out, we could always attribute the funky last few months to her growing, her age, hormones, stress, activity levels, etc. Diabetes is almost a guessing game. You just never know. And we never will.

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