TGA Recall Notice: Urgent Product Defect Correction


Medtronic MiniMed 640G Insulin Pumps with version 4.10 software
Model Numbers: MMT-1711 & MMT-1712 ARTG
Number: 95763 (Medtronic Australasia Pty Ltd Infusion pump, insulin, ambulatory)


Medtronic has confirmed reports of occurrences at a rate of between 0.14% and 0.3% where the MiniMed 640G insulin pump with version 4.10 software has failed to make expected audio sounds during alerts, alarms, or sirens. This 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. Either of these occurrences 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. However, pumps experiencing this issue will continue to deliver insulin as expected.

The issue is characterised by:

  1. Change in audio level that user did not initiate (Piezo volume could be changed to volume OFF (worst case) or to a volume level close to 4);
  2. Inability to change the volume level (volume will remain constant, despite changes to the user settings); and
  3. No audio during escalation of alarm to Siren.