Important Safety Alerts

Medical device manufacturer, Medtronic, has issued a medical device safety alert concerning its MiniMed 600 series insulin pumps. The affected products distributed in Hong Kong are identified as the following: -

• Insulin Pumps: A MiniMed 640G pump; B) MiniMed 670G pump
• Model Numbers: A) MMT-1751H, MMT-1751K, MMT-1751W, MMT-1751WWKA, MMT-1711K; B) MMT-1762 WWKA

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 the pump on a hard surface.

According to the manufacturer, 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.

The affected users are required to take the following actions:

• Examine the retainer ring on the 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 doctor's recommendations.
• Do not insert the reservoir back into the pump while connected because it could mistakenly give them a large insulin bolus and contact the manufacturer.
• If the reservoir properly locks in place by the retainer ring, continue to use the pump. Remember to always follow the Instructions for Use on how to correctly insert the reservoir.
• If by accident user drop or bump the pump, check the pump and retainer ring for damage.
• Routinely examine the pump retainer ring and check that the reservoir locks in place at every set change.

According to the local supplier, the affected products are distributed in Hong Kong.

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 27 November 2019