MiniMed 640G Insulin Infusion Pump
Reason for Recall / Hazard
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.
Product Description & Identification
Reason / 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. 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 to 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.
Affected Products
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)
Additional Source Details
| Field | Value |
|---|---|
| Guid › #text | a93b1a3d-b16c-49f6-ba6d-90cdbe1be7e4 |
| Guid › @ is Perma Link | false |
| Link | https://www.productsafety.gov.au/search-consumer-product-recalls/minimed-640g-insulin-infusion-pump |
| Pub Date | Fri, 08 May 2020 00:00:00 +0000 |