Dexcom Continuous Glucose Monitor Receivers

Official notice

31 Mar 2016

Last checked

31 Mar 2016

Risk not stated by sourceACCC

An official ACCC notice concerns Dexcom Continuous Glucose Monitor Receivers. 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. Published 2016-03-31.

What to do now

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.

Recall number

4e4e8c29-db63-43f4-8c58-f9b364ae7703

Official notice

2016-03-31

The hazard

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.

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Models

DESCRIPTION THE AFFECTED MODELS ARE

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Affected products

Product 1

Dexcom G4 PLATINUM and Dexcom G5 Mobile receiver

Risk / hazard

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.

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

AU · Australia

Affected area 1

AU · Australia

Source & status

Source

Tier

beta

Category

HOME

Classification

Pharmacy and medical products

App estimate

unspecified

Recall details

Recall number

4e4e8c29-db63-43f4-8c58-f9b364ae7703

Classification

Pharmacy and medical products

Source tier

beta

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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