Emergo Australia—Dexcom Continuous Glucose Monitor Receivers

Identifying features

The affected models are:
•Dexcom G4 Platinum Receiver (part number MT20649-2)
•Dexcom G5 Receiver (part number MT22719-2).

What are the defects?

There is a possibility that the audible alarms may not work.

What are the hazards?

Consumers who rely solely on hearing audible alarms or alerts could potentially experience a severe hypoglycemic (low blood glucose) or hyperglycemic (high blood glucose) event.

What should consumers do?

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 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(link sends e-mail) for device replacement and/or advice.

Supplier
Emergo Australia

Responsible regulator

Therapeutic Goods Administration is the responsible regulator for this recall.

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