Medtronic MiniMed Paradigm Insulin Infusion Sets have been recalled, according to an FDA Med Watch report. The recall is due to a malfunction affecting products manufactured from October 2001 through June 2013, and distributed from December 2001 through June 2013.

According to the FDA MedWatch report, the Medtronic MiniMed Paradigm Insulin Infusion Sets have the potential for the over or under delivery of insulin if insulin or other fluids contact the inside of Medtronic Paradigm Tubing Connectors. This can temporarily block the vents that allow the pump to properly prime, resulting in the potential for hypoglycemia or hyperglycemia.

The report states that on June 7, 2013, Medtronic sent an urgent medical device safety notification to healthcare professionals. And on June 2013, the manufacturer sent an Urgent Medical Device Safety Notification to all Paradigm Insulin pump users and distributors.

Health care professionals are advised to follow recommendations listed in the Medical Device Safety Notification letter. Patients are advised to immediately call the HelpLine if they notice anything unusual during the infusion set prime process.

Kommentar; se FDA notice

http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm360618.htm?source=govdelivery

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