Medtronic issues safety letter over insulin pumps

Medtronic has sent a letter to customers using its MiniMed 600 series insulin pumps, alerting them of a potential safety risk.

The letter outlines there have been reports of a loose reservoir that can no longer be locked into the pump. It states the reservoir can become loose due to a broken or missing retainer ring that prevents a proper lock, and says that it can be broken if the pump has been knocked or dropped.

The company has said that users should examine the pump and if the reservoir does not lock into the pump, or if the retainer ring is loose, use of the pump should be discontinued and patients should revert to a back-up plan of manual insulin injections.

The letter from James Dabbs, vice president of quality assurance and regulatory affairs at Medtronic, reads: “If the reservoir is not properly locked into the pump, it could lead to over or under delivery of insulin, which could then result in hypoglycemia or hyperglycemia.

“If the pump retainer ring is broken or becomes detached from the pump, and the user inserts the reservoir back into the pump while the infusion set is still connected to the body, it could result in a rapid infusion of insulin, which could cause hypoglycemia. The under delivery of insulin could occur if the reservoir is not properly locked in place by the retainer ring, creating a space between the pump and the reservoir, and preventing the pump from pushing the expected insulin into the body, which could cause hyperglycemia.”

You can read the full letter here.