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Medtronic Minimed Recalls Quick-Set Plus Infusion Sets.
by TonyAlmeida, Jun 03, 2004 12:00AM
It took a couple of phone calls to the United States FDA and Television News Channel Investigative Teams to finally force Medtronic Minimed, makers of the Paradigm Insulin Pump, to recall about 160,000+ defective Quick-Set Plus infusion sets.
Back in November 2003, Medtronic's Field Trainers testing the new infusion sets were telling Medtronic that the new infusion sets were of a defective design. The infusion sets would jam inside Insertion Devices, inducer needles would get stuck inside the cannulas, the infusion set adhesives would dry up and allow the Quick-Set Plus to come off the patient, and the infusion sets themselves would interrupt the delivery of insulin. Unfortunately, Medtronic dismissed these warnings and discontinued the old Quick-Set infusion sets in December and forced pump users to the new Quick-Set Plus and all of it's engineering defects.
They also switched infusion set manufacturers - so the old manufacturer of the original Quick-Set shut down their plant. All the way up until May - users reported the same problems as the Field Trainers to Medtronic's helpline which told users that THEY (not the infusion set) were causing the problem.
After pressure from the US FDA (and the fact that Medtronic was not reporting defective problems to the FDA as required by law with their new infusion set) - Medtronic is recalling all Quick-Set Plus infusion sets.
If you haven't received a letter from Medtronic (which is doing a poor job of communicating this recall) - call them at 1-800-846-4633 to get replacement sets ASAP for your own safety.
Back in November 2003, Medtronic's Field Trainers testing the new infusion sets were telling Medtronic that the new infusion sets were of a defective design. The infusion sets would jam inside Insertion Devices, inducer needles would get stuck inside the cannulas, the infusion set adhesives would dry up and allow the Quick-Set Plus to come off the patient, and the infusion sets themselves would interrupt the delivery of insulin. Unfortunately, Medtronic dismissed these warnings and discontinued the old Quick-Set infusion sets in December and forced pump users to the new Quick-Set Plus and all of it's engineering defects.
They also switched infusion set manufacturers - so the old manufacturer of the original Quick-Set shut down their plant. All the way up until May - users reported the same problems as the Field Trainers to Medtronic's helpline which told users that THEY (not the infusion set) were causing the problem.
After pressure from the US FDA (and the fact that Medtronic was not reporting defective problems to the FDA as required by law with their new infusion set) - Medtronic is recalling all Quick-Set Plus infusion sets.
If you haven't received a letter from Medtronic (which is doing a poor job of communicating this recall) - call them at 1-800-846-4633 to get replacement sets ASAP for your own safety.
Doctor's Answer
by JDRF-Team-LRS, Jun 03, 2004 12:00AM
I had also been reading the stories by several of my diabetic cyber-pals that they'd experienced sudden sustained changes in their DM management with some of the Quick Set Plus sets. Others were lucky and didn't have the problem.
I've been using the Quick Sets (not plus) with my Cozmo pump for a few months and am very happy with them -- particularly with using the Quick Serter.
Overall, Minimed is an excellent vendor of products for diabetics. However, we all must remain vigilant 'til there's a cure.
I've been using the Quick Sets (not plus) with my Cozmo pump for a few months and am very happy with them -- particularly with using the Quick Serter.
Overall, Minimed is an excellent vendor of products for diabetics. However, we all must remain vigilant 'til there's a cure.
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Again - this is only for the Quick-Set Plus infusion sets. Medtronic pumps and other infusion sets are fine.