PRA number
2020/18322
Published date
Product description
The MiniMed 640G pump is an ambulatory, battery operated, rate programmable micro infusion pump.
The MiniMed 640G pump is intended for continuous insulin delivery and delivery of user activated insulin boluses, for the management of diabetes mellitus in persons requiring insulin.
Product Code: MMT-1711K
Serial Numbers: NG2095284H, NG2095319H
ARTG 95763
(Medtronic Australasia Pty Ltd Infusion pump, insulin, ambulatory)
The MiniMed 640G pump is intended for continuous insulin delivery and delivery of user activated insulin boluses, for the management of diabetes mellitus in persons requiring insulin.
Product Code: MMT-1711K
Serial Numbers: NG2095284H, NG2095319H
ARTG 95763
(Medtronic Australasia Pty Ltd Infusion pump, insulin, ambulatory)
What are the defects?
Certain pumps are missing solder on specific contacts on the Harness Assembly. If the wires make an electrical contact with the Printed Circuit Board Assembly, the lack of solder could result in increased resistance at the connection point, causing early battery depletion.
All necessary battery-related alerts/alarms will still occur to inform the user about the AA battery status.
All necessary battery-related alerts/alarms will still occur to inform the user about the AA battery status.
What are the hazards?
If the battery becomes depleted and the alarm is ignored insulin delivery may be interrupted, this could result in the user developing dangerously high blood glucose levels (hyperglycaemia), which can lead to serious health complications.
What should consumers do?
Medtronic will provide a replacement pump to all affected consumers.
Consumers are advised to record their current pump settings and program the replacement pump provided by Medtronic. Once the replacement pump is successfully programmed and able to be used, consumers are requested to return the affected pump using the shipping materials included with the replacement pump delivery.
For further information, please contact Medtronic Customer Service by phone on 1800 777 808.
Consumers are advised to record their current pump settings and program the replacement pump provided by Medtronic. Once the replacement pump is successfully programmed and able to be used, consumers are requested to return the affected pump using the shipping materials included with the replacement pump delivery.
For further information, please contact Medtronic Customer Service by phone on 1800 777 808.
Supplier
Where the product was sold
Nationally
Responsible regulator
Therapeutic Goods Administration is the responsible regulator for this recall.