PRA number
Published date
Product description
MiniMed Remote Controller MMT-503 used with MiniMed 508 Insulin Pump or Paradigm Pumps
Product code: MMT-503
ARTG: 128416 (Medtronic Australasia Pty Ltd - Remote control - Cancelled)
Reasons the product is recalled
An unauthorised individual in close proximity to an insulin pump user could potentially copy the wireless RF signals from the user’s remote controller and play those back later to deliver an additional bolus of insulin to the pump user or to suspend insulin delivery.
The hazards to consumers
If additional insulin is delivered beyond the user’s insulin requirements, this could lead to hypoglycaemia, or hyperglycaemia if insulin delivery is suspended.
What consumers should do
Remote controller users are advised to immediately stop using and disconnect the remote controller, disable the remote feature, and return the remote controller to Medtronic.
For further information, please contact Medtronic Global Help Line by phone on 1800 777808.
Supplier
Traders who sold this product
Healthcare providers
Where the product was sold
Responsible regulator
Therapeutic Goods Administration is the responsible regulator for this recall.