MiniMed 640G insulin pump

Recall for product correction - potential for user error leading to incorrect dosing

22 July 2015

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

Please note that this product is not being removed from the market. The identified issue is being mitigated with an update to the device's Instructions for Use (IFU).

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

It has been identified that, in certain scenarios in which the insulin pump's message alert screen will not timeout, there is potential for the user to become confused. If this occurs, it may result in the user delivering an incorrect dose (under or over delivery of insulin), which can cause serious health problems.

Specifically, while using the Bolus Wizard function, if the user enters blood glucose and carbohydrate intake details that result in an alert notification, but then becomes distracted and doesn't act on the alert before the device goes into power save mode, there is a risk that they may later progress with a bolus insulin dose that is based on levels that are no longer current.

Information for consumers

Medtronic has written to people who use a MiniMed 640G insulin pump and relevant health professionals to provide further information about this issue, including updated and clarified instructions for using the device and avoiding the above problem.

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

Do not give a bolus insulin dose that was calculated more than 12 minutes prior, as the dose will be based on a blood glucose level that may no longer be accurate. Instead, take a new blood glucose reading and have the Bolus Wizard re-calculate the bolus amount.

If you receive the 'Max Bolus exceeded' warning, you must acknowledge the alert message and then decide whether to complete the intended bolus delivery. If you routinely receive the 'Max Bolus exceeded' warning, notify your health professional so that they can adjust your pump settings.

When calibrating your device, do not respond to a calibration request message that's more than 12 minutes old, as the blood glucose level is no longer considered valid. Always calibrate immediately after testing your blood glucose level.

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 on 1800 777 808 (selecting option 1).

Information for health professionals

Medtronic has written to people who use a MiniMed 640G insulin pump and relevant health professionals to provide further information about this issue, including updated and clarified instructions for using the device and avoiding the above 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 to avoid this problem (see the 'Information for consumers' section above for specific instructions).

In particular, advise them to promptly respond to any alert message displayed on their pump screen.

If you have any questions or concerns about this issue, contact Medtronic 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.