WASHINGTON, D.C. — Medtronic’s MiniMed insulin pump is under recall by the U.S. Food and Drug Administration (FDA). A dosing defect in the machine caused 2,175 injuries or illnesses and killed one person. The FDA said in a recent statement that the Medtronic MiniMed 600 Series have a defective or missing retainer ring. The retainer ring holds the insulin cartridge in place in the reservoir area of the MiniMed. The design defective could permit the insulin cartridge to slip out of place and cause illness or death, according to the New York Post. Medtronic requested every person who is still using its MiniMed 600 series pumps to call a hotline number to discuss safety issues with their technical support team.
The FDA published a warning about the dangers of continuing to use Medtronic’s MiniMed insulin pump after the company recalled the device. A user could sustain severe injuries, illness, or death if the pump fails. Medtronic designed the MiniMed 600 to push insulin into the patient when the patient’s insulin levels drop. However, the design flaw found in the MiniMed 600 prevents the device from administering the proper amount of insulin when needed. As a result, the patient could receive too much insulin and experience hypoglycemia. Alternatively, the pump could deliver too little insulin and allow the patient to experience hyperglycemia. Either extreme can cause seizures in patients and could kill the patient as well.
The FDA has received 26,420 complaints from patients and doctors reporting device malfunctions. Medtronic attempted to contact all of their patients to alert them to the problem. The company instructed consumers to be certain that the insulin cartridge was securing in place and make sure that the ring securing the cartridge was not damaged. Any person who has a defective device must contact his or her doctor and is also advised to contact Medtronic to obtain a replacement pump.
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