The U.S. Food and Drug Administration (FDA) just announced a recall of Medtronic’s MiniMed Paradigm Insulin Infusion Sets due to the potential of over or under delivery of insulin. The agency deemed the recall a Class 1, which means that this recall situation involves a reasonable probability that the use of, or exposure to, the violative product—in this case, the Medtronic MiniMed Paradigm Insulin Infusion device—will cause serious adverse health consequences or death.
Device maker, Medtronic issued an urgent medical safety device notification on June 7, 2013, to health care professionals advising of the potential for over or under delivery of insulin or other fluids should those fluids come into contact with the inside of Medtronic Paradigm Tubing Connectors. Medtronic then sent an Urgent Medical Device Safety Notification to all Paradigm Insulin pump users and distributors to inform them of this issue. That notification was sent on June 10, 2013.
Should insulin or other fluids come in contact with the inside of the tubing connector, the vents that allow the pump to properly prime may be temporarily blocked. This blockage can cause too little or too much insulin to be delivered, which may result in hypoglycemia or hyperglycemia, either of which can be severe and can lead to serious illness.
The recalled Medtronic devices were manufactured from October 2001 through June 2013 and were distributed from December, 2001 through June, 2013. MedPage Today noted that the recall involves affects 37 models of Medtronic’s Paradigm infusion sets. A complete list of affected devices can be accessed here.
The Medtronic infusion sets are used by patients with diabetes mellitus who require administered insulin to maintain an acceptable blood glucose level. The recalled Medtronic Paradigm infusion sets are meant to be used with Paradigm insulin infusion pumps.
Medtronic advises patients that if anything unusual is noticed during the infusion set prime process, such as the insulin continuing to drip from the tip of the infusion set cannula when priming has been completed, this may indicate that the connector vents are not working properly. Should this occur, patients are advised not to insert the infusion set and to immediately call the HelpLine, toll-free, at 1.888.204.7616 for assistance.
Medtronic noted that healthcare professionals do not need to take additional action beyond the recommendations provided in the Urgent Medical Device Safety Notification letter. Also, healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program by completing and submitting the report online at www.fda.gov/MedWatch/report.htm or calling the FDA, toll-free, at 1.800.332.1088 to request a reporting form, and completing and returning the form to the indicated address or submit the form, by fax, to 1.800.FDA.0178.