Insulin Infusion Set Recall

By Diane Fennell

On July 7, 2013, the US Food and Drug Administration (FDA) reclassified Medtronic's voluntary June recall of Medtronic Minimed Paradigm infusion sets as a class I recall (the most serious type of recall). The recall was initiated because the infusion sets have the potential to cause over- or under-delivery of insulin, which could result in low or high blood glucose levels.

If insulin or other fluids come in contact with the inside of the connector on Medtronic Paradigm infusion sets, the liquid can temporarily block the vents in the connector that allow the pump to properly prime. If the vents are blocked, this can lead to too much or too little insulin being delivered, potentially resulting in hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose). According to Medtronic, " Exposure of the inside of the infusion set connector to fluid is most likely to occur if insulin is spilled on the top of the insulin reservoir when the reservoir is removed from the transfer guard after filling the reservoir from a vial of insulin."

The following thirty-seven models of the infusion set are affected: MMT-317, MMT-318, MMT-324, MMT-325, MMT-312S, MMT-312L, MMT-386, MMT-387, MMT-394, MMT-396, MMT-397, MMT-398, MMT-399, MMT-377, MMT-378, MMT-381, MMT-382, MMT-383, MMT-384, MMT-368, MMT-862, MMT-864, MMT-866, MMT-874, MMT-876, MMT-884, MMT-886, MMT-921, MMT-923, MMT-925, MMT-941, MMT-943, MMT-945, MMT-961, MMT-963, MMT-965, & MMT-975.

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Source: Diabetes Self-Management - July 19, 2013 Category: Diabetes Authors: Diane Fennell Source Type: blogs