MiniMed 600 series insulin pump – Pump retainer ring

25 November 2019

TGA Reference: RC-2019-RN-01694-1 MiniMed 640G: MMT-1711, MMT-1712 MiniMed 670G: MMT-1782

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 hypoglycaemia or hyperglycaemia.

  • 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 hypoglycaemia. 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 preventing the pump from pushing the expected insulin into the body, which could cause hyperglycaemia.

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.

Action Required:

  1. Examine the retainer ring on your pump.
  2. 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 contact our Medtronic 24-Hour Technical Support line at 1800 777 808.
  3. 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.

Download: MiniMed 600 series insulin pump – pump retainer ring safety alert

PRECAUTIONS RECOMMENDED FOR ALL PATIENTS

  1. If by accident you drop or bump your pump, check your pump and retainer ring for damage.
  2. Routinely examine your pump retainer ring and check that your reservoir locks in place at every set change.

Additional Information:

Medtronic is issuing this notice in consultation with the Therapeutic Goods Administration.

Contact Details:

If you continue to experience issues or have questions, please contact Medtronic's Global Help Line on 1800-777-808.