Last Updated on October 16, 2021 by The Health Master
The Central Drugs Standard Control Organisation (CDSCO) has issued medical device alert on a series of insulin pumps and pump kits of global devices major Medtronic, as the specific faulty devices could result in rapid and potentially large infusion of insulin causing hypoglycemia on its users.
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,” said the CDSCO alert.
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.
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, it added.
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 to 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. However, CDSCO has not received any complaints from the market on this issue, it added.
Last week, the company has informed US Food and Drugs Administration (USFDA) 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, it said. The USFDA has identified this as a Class I recall, the most serious type of recall.
The company communicated about the recall for the first time in November, 2019 in the US, with instructions for customers to examine pumps for potential retainer ring damage and to contact Medtronic if the ring appeared to be loose, damaged or missing. On October 5, 2021, the company notified its customers in the US by email and phone that the recall has been expanded to replace all MiniMed 600 series pumps that contain the clear retainer ring.