Dexcom continuous glucose monitor receivers

Consumers and health professionals are advised that Emergo Australia, in consultation with the TGA, is undertaking a recall for product correction of two models of Dexcom continuous glucose monitor receivers due to the possibility that the audible alarms may not work.

Continuous glucose monitor receivers form part of glucose monitoring systems used to measure blood glucose levels in people with diabetes. In these systems, a sensor embedded in the skin sends regular data regarding blood glucose levels to a receiver that tracks changes and alerts the user to any actions needed.

The affected models are:

• Dexcom G4 Platinum Receiver (part number MT20649-2)
• Dexcom G5 Receiver (part number MT22719-2).

Emergo Australia has advised that the manufacturer, Dexcom, identified the issue following overseas reports of alarms and alerts not working.

Consumers who rely solely on hearing audible alarms or alerts could potentially experience a severe hypoglycaemic (low blood glucose) or hyperglycaemic (high blood glucose) event. There have been no reports of such events occurring in Australia due to this issue.

If audible alarms and alerts are not working, vibration alerts should still be functioning. The vibration function for the alarms and alerts cannot be disabled by the user.

Dexcom is working to fix the issue affecting audible alarms and alerts.

Information for consumers

If you or someone you care for has an implanted glucose sensor, check if it the continuous glucose monitor receiver matches the model and part numbers listed above (the part number will be on the back of the device).

If you have one of the potentially affected models, you should check if the alarms and alerts are functioning properly by following the instructions listed in the 'Additional information' section below or in the Instructions for Use for your device. Emergo Australia advises that such testing should be undertaken periodically, particularly if the receiver gets wet or is dropped.

If your receiver's audible alarms and alerts are not functioning properly, or if you have any questions regarding this issue, contact the local distributor Australasian Medical and Scientific toll free on 1300 851 05 or email diabetes@amsl.com.au for device replacement and/or advice.

Information for health professionals

If you are treating a patient who uses a Dexcom continuous glucose monitor receiver, alert them to this issue and advise them to check if they have one of the potentially affected models listed above.

Advise them to check if the alarms and alerts are functioning properly by following the instructions listed in the 'Additional information' section below or in the Instructions for Use for their device.

Advise them to contact Australasian Medical and Scientific toll free on 1300 851 05 or email diabetes@amsl.com.au if they have any questions or concerns.

Additional information

To check whether your Dexcom continuous glucose monitor receiver's audible alarms and alerts are functioning use the 'Try It' feature under the 'Profiles' option in the 'Main Menu' of your receiver.

The steps to follow are:

1. Press the centre button on your receiver to access the 'Main Menu'
2. Scroll down to 'Profiles'
3. Select 'Profiles'
4. Scroll down to 'Try It'
5. Select 'Try It'
6. Scroll down to '3.1 Fixed Low' (for mmol/L) as applicable for your type of receiver
7. Select '3.1 Fixed Low' as applicable for your type of receiver
8. Verify that you receive vibrations first (vibratory portion of alarm), followed by beeps (audible portion of alarm).

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.