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The recalled MiniMed 600 Series models either had a missing or broken retainer ring which helps to lock the insulin cartridge into place in the pump's reservoir compartment, the FDA said Wednesday. If the cartridge is not locked into place, an inaccurate amount of insulin may be delivered, which can result in hypoglycemia, low level of blood sugar(glucose) or hyperglycemia, an excess of sugar (glucose) in someone's system, the FDA warned. Severe hyperglycemia can result in a loss of consciousness, seizures and death.
Insulin pumps, used to manage diabetes, are computerized devices that deliver small doses of insulin, helping diabetics reach their target blood glucose levels.
The medical device company initiated the recall in November after discovering it's MiniMed 600 Series insulin pumps were delivering inaccurate does of insulin, according to the FDA.
"There have been reported incidents of a loose reservoir that can no longer be locked into the pump," the company said in a statement to customers in November. "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.
Approximately 322,005 devices have been affected.
The recalled products include the following:
- Model 630G.(Model number: MMT-1715): This model was distributed between September 2016 to October 2019.
- Model 670G (Model number: MMT-1780): This model was distributed between June 2017 to August 2019.
The pump model number can be found directly on the bottom or on the back of the device.
The FDA says the Model 630G insulin pump may be used by those 16 years of age and older. The Model 670G insulin pump may be used by anyone 14 years of age and older.
The company has received approximately 26,421 complaints regarding the device malfunctioning in this manner. To date, the firm is aware of 2,175 injuries and one death, the FDA said.
The FDA has identified this as a Class I recall, which is the most serious type of recall.
Customers who have questions about this recall should call the 24-hour Medtronic Technical Support at 877-585-0166.