PRA number
2016/15288
Published date
Product description
Dexcom G4 PLATINUM and Dexcom G5 Mobile receiver
Why the product is recalled
There is a possibility that the audible alarms may not work.
What the hazards are 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.
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.