PRA number
2018/17107
Published date
Product description
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
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
Reasons the product is 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.
The hazards to consumers
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.
If this issue occurs, audio cannot be permanently repaired or regained.
Pumps experiencing this issue will continue to deliver insulin as expected.
What consumers should do
Users of Medtronic MiniMed 640G Insulin Pumps will be contacted by mail for further information.
However, in the meantime consumers should comply with the following precautionary steps:
- Ensure the vibrate and audio features are enabled on devices.
- Perform an audio beep test to identify pumps that may be experiencing this potential issue. The test will identify if the pump's audio is working. Instructions for conducting the test can be found at http://www.medtronicdiabetes.com/checkaudio
In the event that the audio beep test fails, consumers are advised to contact Medtronic to start the replacement process.
Where the audio beep test passes, users are advised to repeat the audio beep test as a matter of routine along with every set change and once mid-way through the infusion set with continued use of the pump, or whenever users notice they may have not heard an alert or alarm that was displayed on the screen or resulted in a vibration.
For further information, contact the Medtronic Customer Support Line on 1800 777 808.
However, in the meantime consumers should comply with the following precautionary steps:
- Ensure the vibrate and audio features are enabled on devices.
- Perform an audio beep test to identify pumps that may be experiencing this potential issue. The test will identify if the pump's audio is working. Instructions for conducting the test can be found at http://www.medtronicdiabetes.com/checkaudio
In the event that the audio beep test fails, consumers are advised to contact Medtronic to start the replacement process.
Where the audio beep test passes, users are advised to repeat the audio beep test as a matter of routine along with every set change and once mid-way through the infusion set with continued use of the pump, or whenever users notice they may have not heard an alert or alarm that was displayed on the screen or resulted in a vibration.
For further information, contact the Medtronic Customer Support Line on 1800 777 808.
Supplier
Where the product was sold
Nationally
Responsible regulator
Therapeutic Goods Administration is the responsible regulator for this recall.