Medtronic has recalled certain MiniMed 600 Series insulin pumps for delivering incorrect insulin dosing.
(CNN)Medtronic has recalled some of its insulin pumps after injuries and one death were reported due to the device malfunctioning, according to a US Food and Drug Administration announcement on Wednesday.
The FDA identified it as a Class I recall, the most serious type of recall.
Insulin pumps are small devices that can deliver insulin and help diabetes patients reach desired blood glucose levels as part of their management of the disease.
Medtronic has recalled certain MiniMed 600 Series insulin pumps for delivering incorrect insulin dosing due to a missing or broken retainer ring, which helps lock the insulin cartridge in place in the pump’s reservoir compartment, the FDA announcement said. The recall includes about 322,000 devices.
“There have been reported incidents of a loose reservoir that can no longer be locked into the pump. The reservoir can become loose due to a broken or missing retainer ring that prevents a proper lock. The retainer ring can be broken, for example, as a result of dropping or bumping your pump on a hard surface,” said a safety notification letter that Medtronic sent to patients in November.
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