WASHINGTON, D.C. — Medtronic, the medical device manufacturer, based in Dublin, Ireland, announced an urgent recall of its MiniMed Insulin Pumps in the 600 Series. The pumps reportedly contain a defective retainer ring. The broken retainer ring cannot hold the insulin cartridge in place securely, thereby causing the pump to dispense a dose different than prescribed. So far, Medtronic is aware of one person dying because of the defect and other 2,175 injuries related to the defective insulin pumps. The U.S. Food and Drug Administration, or FDA for short, declared the MiniMed recall campaign to be worthy of a Class I recall designation according to MD+DI Online.
Medtronic said that it began notifying customers about the possible retainer ring problem back in mid-November of 2019. Medtronic called its actions “proactive.” Whatever label the company wants to apply to its efforts, one person is now dead, and an astounding 2,175 other diabetics sustained various injuries because of Medtronic’s defective MiniMed 600 Series Insulin Pump.
Medtronic identified the cause of the problem as a defective or missing retainer ring. The pump’s retainer ring holds the insulin cartridge in place. The pump will deliver either too much insulin or an insufficient amount of insulin, depending upon how the reservoir sits in the pump. Too little insulin will cause the person to become hyperglycemic. A person suffering from hyperglycemia could cause the person to lose consciousness, begin suffering seizures, and then die as a result. Too much insulin will force a person into a state of hypoglycemia or having blood sugar levels that are too low.
Medtronic advised its customers to inspect their insulin pumps for the displacement of the retainer ring after the patient has completed the infusion set and reservoir change. The company asked its customers to be sure that the reservoir is securely in place. Medtronic also said that anyone who experiences a problem with the pump should contact Medtronic and discontinue using the pump. The patient should also contact his or her physician.
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