PRA number
2017/15938
Published date
Product description
MiniMed 640G insulin pumps with software version 2.6, model number MMT-1711.
The MiniMed 640G is a portable insulin pump that is used to help people with diabetes maintain normal blood glucose levels.
ARTG Number 95763.
This is a recall for product correction - the pumps are not being physically recalled and are not being removed from the market.
The MiniMed 640G is a portable insulin pump that is used to help people with diabetes maintain normal blood glucose levels.
ARTG Number 95763.
This is a recall for product correction - the pumps are not being physically recalled and are not being removed from the market.
Reasons the product is recalled
Medtronic has identified a software issue that could prevent the internal battery from charging on some MiniMed 640G insulin pumps. If the issue occurs, an alarm is triggered and patients will see "Power error detected" and "25" displayed on the pump screen (power error 25). The message states "Delivery stopped. Record your settings by uploading to CareLink or write your settings on paper. See User Guide."
The hazards to consumers
Potential loss of therapy due to battery power error.
If the alarm is ignored and no action is taken to correct the problem, the user could develop dangerously high blood sugar levels (hyperglycaemia) which can cause serious health problems.
If the alarm is ignored and no action is taken to correct the problem, the user could develop dangerously high blood sugar levels (hyperglycaemia) which can cause serious health problems.
What consumers should do
If you or someone you provide care for use a MiniMed 640G insulin pump, you should respond promptly to any alert message displayed on the pump screen. If you encounter the "25" error, you should call the 24-hour Medtronic Helpline on 1800 777 808 (selecting option 1) for assistance. Callers will be assisted to determine the cause of the alarm and be guided through the pump reset process.
If the error cannot be corrected, the pump will be replaced.
This is a recall for product correction - the pumps are not being physically recalled and are not being removed from the market.
Medtronic Australasia has written to people who use a MiniMed 640G insulin pump, as well as to relevant health professionals to provide further information about this issue.
If you have any questions or concerns about this issue, speak to your diabetes nurse educator or other health professional. Alternatively, you can contact Medtronic Australasia on 1800 777 808 (option 1).
If the error cannot be corrected, the pump will be replaced.
This is a recall for product correction - the pumps are not being physically recalled and are not being removed from the market.
Medtronic Australasia has written to people who use a MiniMed 640G insulin pump, as well as to relevant health professionals to provide further information about this issue.
If you have any questions or concerns about this issue, speak to your diabetes nurse educator or other health professional. Alternatively, you can contact Medtronic Australasia on 1800 777 808 (option 1).
Supplier
Medtronic Australasia Pty Ltd
Where the product was sold
Nationally
Responsible regulator
Therapeutic Goods Administration is the responsible regulator for this recall.