Issue Description: 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. The retainer ring can be broken, for example, as a result of dropping or bumping your pump on a hard surface.
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. For example, 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 prevent the pump from pushing the expected insulin into the body, which could cause hyperglycemia.
This issue may affect users on the MiniMed™ 600 series insulin pump. The pump model number can be found directly on the bottom or on the back of the device.
MiniMed™ 630G insulin pump: MMT-1715
MiniMed™ 670G insulin pump: MMT-1780
Examine the retainer ring on your pump.
If the reservoir does not lock into the pump or the retainer ring is loose, damaged or missing, discontinue using the insulin pump and revert to a back-up plan of manual insulin injections per your doctor’s recommendations. DO NOT insert the reservoir back into your pump while connected because you could mistakenly give yourself a large insulin bolus, and go to www.medtronicdiabetes.com/PumpRing or contact the Medtronic 24-Hour Technical Support line at 1-877-585-0166.
If your reservoir properly locks in place by the retainer ring, continue to use your pump. Remember to always follow the Instructions for Use on how to correctly insert the reservoir.
PRECAUTIONS RECOMMENDED FOR ALL PATIENTS:
If by accident you drop or bump your pump, check your pump and retainer ring for damage.
Routinely examine your pump retainer ring and check that your reservoir locks in place at every set change.
Please visit www.medtronicdiabetes.com/PumpRing for additional information and answers to frequently asked questions.
If you have further questions or need assistance, please call Medtronic's 24-Hour Technical Support at: 1-877-585-0166.