Medtronic—MiniMed Infusion Sets: Fluid May Block Infusion Set Membrane during Priming/Fill-Tubing Process, Potentially Causing Overdelivery of Insulin

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​In a September 7, 2017, Urgent Medical Device Recall letter submitted by an ECRI Institute member hospital, Medtronic states that it has received reports of potential overdelivery of insulin shortly after the above infusion sets were changed. Medtronic also states that overdelivery of insulin can cause hypoglycemia and in extreme cases, death. Medtronic further states that fluid may block the membrane of the above infusion sets during the priming/fill-tubing process. A membrane blocked by fluid most likely occurs if insulin, alcohol, or water is spilled on top of the insulin reservoir, which could prevent the infusion set from working properly. The firm has received reports of hypoglycemia requiring...