Product description

Dexcom G4 PLATINUM and Dexcom G5 Mobile receiver

See a list of details to help identify the product

Reason the product is recalled

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

The hazards to consumers

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 consumers should 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.

Details to help identify the product

Supplier running the recall

Emergo Australia

Identifying product features

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

Identifying numbers

Other identifying numbers

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

Responsible regulators

Regulators are established or appointed by government. They enforce regulations and rules.

Quote PRA number 2016/15288 when contacting a regulator about this recall.

Recall and remedy questions

Contact the Therapeutic Goods Administration if you have:

  • a question about the remedy being offered to you by the business that is responsible for managing this recall, or
  • concerns about the way the business is managing this recall.