September 8, 2014 — Medtronic is recalling the MiniMed Paradigm insulin pump after receiving reports from customers who accidentally programmed the device to deliver the maximum amount of insulin, including one report from a patient who suffered extreme hypoglycemia (low blood sugar).
Although serious adverse events have been reported, the FDA has classified this a a Class II recall.
Extremely serious low blood sugar can cause symptoms like trembling, excessive sweating, weakness, hunger, confusion, and headache. In extreme cases, it could cause loss of consciousness, seizure, or death.
According to the recall notification:
“…because accidental button pressing errors may occur it is important that customers always confirm the insulin dose flashing on the display is correct before pressing ACT to start delivery.”
Medtronic sent an Important Medical Device Safety Information (PDF) letter to their customers on March 13. The recall affects about 560,000 insulin pumps with model numbers MMT-511, MMT-512/712/712E, MMT-515/715, MMT-522/522K/722/722K, MMT-523/523K/723/723K, and MMT-551/751.
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