Any person with diabetes who uses an affected Medtronic Minimed Insulin Pump or Health Care provider who treat people with diabetes using the affected MiniMed Insulin Pump may cause hyperglycaemia (excess glucose in blood). This has been revealed by the Central Drugs Standard Control Organisation (CDSCO) through its recent Medical Device Alert. This CDSCO alert on a series of insulin pumps and pump kits of global devices major Medtronic said, though it has not received any complaints from the market on this issue, CDSCO has issued the alert as a precaution to its users. CDSCO has attached the Field Safety Notice issued by M/S India Medtronic Pvt Ltd Gurgaon Haryana with the alert. After the inclusion of Medical Devices under Drugs and Cosmetic Act, third such alert has been issued by CDSCO. CDSCO mentioned, “The MiniMed 600 series insulin pump is designed with a pump retainer ring to lock the reservoir in the insulin pump. There have been reports 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.”

 

“If the retainer ring is damaged, loose or missing, and the user inserts a reservoir back while the infusion set is still connected to the body, it could result in rapid and potentially large infusion of insulin, which could cause hypoglycemia. Severe hypoglycemia can be life-threatening or may result in death. Under-delivery could occur if the reservoir is not properly locked, creating space and preventing pup from pushing expected insulin into the body, of if the pump stops working due to water ingress, which could cause hyperglycemia,” CDSCO added. Medtronic on its own has started recalling the insulin pumps and informed CDSCO regarding the same. The company has given a reason for recall as, “Medtronic is recalling the specified insulin pumps to replace any pump that has a clear retainer ring with one that has the updated black retainer ring at no charge. A replacement insulin pump will be provided even if the clear retainer ring is not damaged and regardless of the warranty status of the pump.”

 

“The company, earlier identified, and informed customers about missing or broken clear retainer rings of the MiniMed 630G and 670G insulin pumps. The retainer ring helps lock the insulin cartridge into place in the pump’s reservoir compartment. If the cartridge is not locked firmly in low blood sugar or high blood sugar. Severe hyperglycemia and hypoglycemia can be life-threatening or may result in death. Serious injuries and deaths have been reported with the use of MiniMed 600 series insulin pumps, however those adverse events may not have been directly related to the damaged clear retainer rings that are the basis of this recall, it said. 

 

Medtronic recalled 4,63,464 MiniMed 600 series insulin pumps According to a report, few days ago, Medtronic has informed US Food and Drugs Administration (FDA) that it has recalled 4,63,464 devices in the MiniMed 600 series of insulin pumps stating that the company will replace any pump in the series that has a clear retainer ring with one that has the updated black retainer ring at no charge. The replacement insulin pump will be provided even if the clear retainer ring is not damaged and regardless of the warranty status of the pump.