CDSCO raises alert on Medtronic MiniMed 600 Series Insulin Pumps

This Medical Device Alert comes in line with Medtronic's Field Safety Notice, which states that MiniMed Insulin Pumps are being recalled due to incorrect insulin dosing. The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

The MiniMed insulin pump is used by people with Type 1 diabetes to deliver insulin for diabetic management.

• The Model 630G insulin pump may be used by persons sixteen years of age and older.

• The Model 670G insulin pump may be used by persons seven years of age and older.

The MiniMed 600 series insulin pump is designed with a pump retainer ring to lock the reservoir in the insulin pump.

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.

If the retainer ring is damaged, loose, or missing, and the user inserts the 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.

Further, under-delivery could occur if the reservoir is not properly locked, creating space and preventing the pump from pushing expected insulin into the body, or if the pump stops working due to water ingress, which could cause hyperglycemia.

In this regard, Medtronic previously identified and informed customers about a missing or broken clear retainer ring of the MiniMed 630G and 670G insulin pumps.

In light of the above mentioned risk, Medtronic started 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.

It is said that 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.

Medtronic stated in the Field Safety Notice outlining the reason for the recall,

The retainer ring helps to lock the insulin cartridge into place in the pump's reservoir compartment.

If the cartridge is not locked firmly into place, under or over delivery of insulin may occur, which could result in low blood sugar (hypoglycemia) or high blood sugar (hyperglycemia). Severe hyperglycemia and hypoglycemia can be life-threatening or may result in death.

Example of hypoglycemia risk: If the retainer ring is broken or becomes detached from the insulin 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 and potentially large infusion of insulin.

Example of hyperglycemia risk: 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 insulin pump and the reservoir, and preventing the pump from pushing the expected insulin into the body, or if the pump stops working due to water entering the insulin pump. This may also contribute to diabetic ketoacidosis.

Serious injuries and deaths have been reported with the use of MiniMed 600 series insulin pumps, but those adverse events may not have been directly related to the damaged clear retainer rings that are the basis for this recall.

Further, as per the Field Safety Notice, the following people may be affected

• Any person with diabetes who uses an affected Medtronic MiniMed insulin pump

• Health care providers who treat people with diabetes using the affected MiniMed insulin pumps.

However, in response to the foregoing, CDSCO noted that COSCO has not received any market complaints on this matter.

On October 5, updating the safety alert, Medtronic stated

"Medtronic updated this recall with information that Medtronic will replace any MiniMed 600 series insulin 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. If you have questions about this recall, call Medtronic's 24-Hour Technical Support line: 1-877-585-0166."

Medtronic provided the following updated recommendations to customers:

• Determine if you have a clear retainer ring.

 Users can visit www.medtronicdiabetes.com/retainer-ring-serial-number-look-upExternal Link Disclaimer and enter the serial number of the pump to check to confirm that the pump has a clear retainer ring.

• Examine the retainer ring of the pump.

• If the retainer ring is loose, damaged, or missing or the reservoir does NOT lock into the pump:

 Stop use of the pump and contact Medtronic for a replacement pump. If you stop using the pump, you should follow your doctor's recommendations and perform manual insulin injections. DO NOT insert the reservoir back into your pump while connected because you could mistakenly give yourself a rapid, and possibly large, insulin bolus.

• If the reservoir locks in place correctly and the retainer ring is not loose, damaged, or broken:

 Continue using the pump until you receive your replacement pump.

 Follow instructions provided by Medtronic to replace and use the pump.

Further it added, "check your current and new pump and retainer ring for damage every time you replace the insulin reservoir, or any time it is dropped or bumped."

In November 2019, Medtronic first communicated about this recall with instructions for customers to examine pumps for potential retainer ring damage and to contact Medtronic if the retainer ring appeared to be loose, damaged or missing.

.To view the official notice, click the link below: