The US Food and Drug Administration (FDA) has announced that Medtronic recalled some of its insulin pumps after injuries and one death were reported due to malfunction.
The FDA said Medtronic issued a Class I recall, the most serious type of recall, for some of its MiniMed 600 Series insulin pumps after reports that the device malfunctioning led to injuries and one death.
These devices are used to deliver insulin and help diabetes patients reach the desired blood glucose levels as part of their disease management.
In the announcement, the FDA indicated that Medtronic recalled certain MiniMed insulin pumps for delivering incorrect insulin dosing due to a missing or broken retainer ring. The ring helps lock the insulin cartridge in place in the pump's reservoir compartment.
According to the FDA, there have been 26,421 complaints regarding device malfunction, 2,175 injuries and one death.
The pump models involved in the recall are Model 630G distributed in September 2016 to October 2019 and Model 670G distributed in June 2017 to August 2019. The number of devices affected by the recall amounted to around 322,000 units.
In a safety notification letter sent by Medtronic to patients in November, the company said: "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."
"At Medtronic, patient safety is our top priority, and we are committed to delivering safe and effective therapies of the highest quality and reliability possible. We appreciate your time and attention in reading this important notification," the company assured.
The FDA encourages patients using the pumps to contact Medtronic for a replacement pump if the reservoir does not lock into place properly or if the retainer ring is loose, damaged or missing.
