Medtronic MiniMed™ 640G Insulin Infusion Pump
Published 12 November 2018
Product
The MiniMed 640G Insulin Pump (models MMT-1711 & MMT-1712) 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. This recall affects MiniMed 640G Insulin Pumps with version 4.10 software ARTG Number: 95763
Why it was recalled
The MiniMed 640G Insulin pump with version 4.10 software has failed to make expected audio sounds during alerts, alarms and sirens. The failure could either cause the alarm volume to be stuck at a 4 (out of 5) level regardless of personal settings, or it could make no sound.
Hazard
Failure of expected audio sounds could cause users to miss system notifications, alarms or sirens associated with how the pump is working, and with high and low glucose alerts. If this issue occurs, audio cannot be permanently repaired or regained. Pumps experiencing this issue will continue to deliver insulin as expected.
Source: Product Safety Australia. RecallMatch AU provides a screening summary and is independent of the ACCC.