Medtronic Australasia Pty Ltd — MiniMed 640G and 670G Insulin Pumps

PRA number

2021/19227

Published date

Product description

MiniMed 640G insulin pump
An ambulatory, battery-operated, rate-programmable microinfusion pump.
Model numbers: MMT-1711 and MMT-1712

MiniMed 670G insulin pump
An insulin pump intended for continuous delivery and delivery of user activated insulin boluses.
Model numbers: MMT-1762 and MMT-1782

Only pumps with a clear pump retainer ring

ARTG 95763
(Medtronic Australasia Pty Ltd Infusion pump, insulin, ambulatory)

ARTG 308140
(Medtronic Australasia Pty Ltd - Infusion pump, insulin, ambulatory)

Reasons the product is recalled

If the pump retainer ring breaks, the reservoir may become loose and may not lock into the pump.

The hazards to consumers

If the retainer ring is damaged, loose or missing, this may lead to under delivery of insulin, which may cause hyperglycemia. If a user inserts the reservoir back in while the infusion set is still connected to the body, there may be a rapid infusion of insulin, which may cause hypoglycemia or death.

What consumers should do

If the reservoir does not lock into the pump or the retainer ring is loose, damaged or missing, consumers should immediately discontinue using the insulin pump and revert to a back-up plan with the healthcare provider’s recommendations. Do not insert the reservoir back into the pump while connected.

If the reservoir properly locks in place with the retainer ring and the retainer ring is not loose, damaged, or broken, consumers may continue to use their pump until they receive a replacement pump.

In the interim, consumers should inspect the retainer ring on the pump and examine the retainer ring for damage every time the infusion set is changed.

The supplier will contact affected consumers and direct them to visit https://info.medtronicdiabetes.com/Clear_Retainer_Ring, call the Medtronic Global Help Line on 1800 777 808, or complete and return the Confirmation Form to receive a replacement pump at no charge.

Traders who sold this product

Healthcare providers

Where the product was sold

Nationally
International

Dates available for sale

-

Responsible regulator

Therapeutic Goods Administration is the responsible regulator for this recall.

Product category

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