MiniMed 640G insulin pump

Recall for product correction - potential loss of therapy due to power error

17 February 2017

Consumers and health professionals are advised that Medtronic Australasia, in consultation with the TGA, has initiated a recall for product correction of the MiniMed 640G insulin pump.

MiniMed 640G insulin pumps are portable devices used to help people with diabetes maintain normal blood glucose levels.

It has been identified that a software issue could prevent the internal battery of the pump from charging. This will trigger an alarm and a 'Power error detected' message and the number '25' will be displayed on the pump’s screen. The message states 'Delivery stopped. Record your settings by uploading to CareLink or write your settings on paper. See User Guide.'

If this message is displayed, the user should contact the Medtronic Helpline on 1800 777 808 (selecting option 1) for assistance with resetting pump to correct the problem. If the error cannot be corrected, the pump will be replaced.

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.

Information for consumers

Medtronic Australasia has written to people who use a MiniMed 640G insulin pump and could potentially be affected, as well as to relevant health professionals, to provide further information about this issue.

Please note that this product is not being removed from the market.

If you or someone you provide care for uses a MiniMed 640G insulin pump, respond promptly to any alert message displayed on the pump screen.

If you receive a 'Power error detected' message accompanied by the number '25', contact the Medtronic Helpline on 1800 777 808 (selecting option 1) for assistance with resetting the pump to correct the problem. If the error cannot be corrected, the pump will be replaced.

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).

Information for health professionals

Medtronic Australasia has written to people who use a MiniMed 640G insulin pump and relevant health professionals to provide further information about this issue.

Please note that this product is not being removed from the market.

Newer pumps have new software that corrects this potential problem.

If you are treating patients who use MiniMed 640G insulin pumps, please ensure that they are aware of this issue and what they should do if they receive a 'Power error detected' message accompanied by the number '25' (see the 'Information for consumers' section above for specific instructions).Advise them to respond promptly to any alert message displayed on their pump screen.If you have any questions or concerns about this issue, contact Medtronic Australasia on 1800 777 808 (selecting option 1).

Reporting problems

Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).

The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.