With a sizable percentage of nursing home patients diagnosed with diabetes, we have been contacted by a number of current and former clients regarding a product recall involving Medtronic’s MiniMed Paradigm insulin pumps. The medical device recall was initiated in July, 2009 after defects were discovered in a particular lot of the infusion sets.
The recalled infusion sets can be identified by both the lot number (Lot 8, Quick-set infusion sets) and the reference numbers: MMT-396, MMT-397, MMT-398 and MMT-399 (lots starting with a number ‘8’).
The problems with the infusion sets identified above is that the tubing may not allow the insulin pump to vent the pressure properly with may result in the patient receiving too much or too little insulin which in turn could result in a severe injury or death.
According to Medtronic, if your loved one uses a ‘Quick-Set’ Infusion Set and is used identified within the lots above, you should stop using the device immediately.
Further, if you believe your loved one died or suffered an injury including: hypogylcemia or hyperglycemia following use of a Medtronic infusion device, you may be entitled to compensation from the manufacturer. In order to determine if your case fits within the parameters, you should safeguard the packaging and contact a medical device attorney for a consultation.
Medtronic Voluntarily Recalls Specific Lots of Paradigm® Quick-Set® Infusion Sets In The United States, FDA July 10, 2009