MIAMI, Fla. — The international medical device maker Medtronic announced a recall of several lots, or groups, of its 600 Series MiniMed Insulin Pumps. The U.S. Food and Drug Administration (FDA) reportedly announced that this recall program initiated by Medtronic is a Class I recall. The FDA justified its decision to label this recall as the most-urgent by announcing that it received nearly 27,000 complaints of defects from patients, learned of 2,175 injuries, and one death because of the malfunctioning device. According to the Miami Herald, the defective MiniMed Insulin Pumps in Medtronic’s 600 Series ether have no retainer ring or have a broken retainer ring. The pump’s retainer ring holds the insulin cartridge in place, and the device cannot deliver the prescribed dose of insulin if the round falls out of place.
The Medtronic MiniMed recall concerns 322,005 Series 600 Insulin Pumps. The FDA said that all lots of the MiniMed Insulin Pump Model 630G made before October of 2019, and all lots of the MiniMed 670G model made before August of 2019 are subject to the recall. Any person wearing one of these insulin pumps must report the recall to their physician, who will replace the pump with a pump that functions correctly. Additionally, Medtronic advised patients to stop using the pump and commence manual injections. Medtronic said that it began notifying its patients in November of 2019. There was no information about the number of complaints that the company received about malfunctioning units before that date.
The malfunction in the 600 Series Insulin Pumps concerns the retainer ring. The retainer ring holds the insulin cartridge in place. The pump will malfunction and deliver an improper dose. An inadequate dose could cause insulin levels to spike and sent the patient into hypoglycemia. More significantly, too little insulin could cause the patient’s blood sugar to spike and become hyperglycemic. A person with severe hyperglycemia could fall unconscious, experience seizures, and could die.
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