Events

Recall of Dexcom G4 PLATINUM and Dexcom G5 Mobile receiver (Continuous Glucose Monitoring Device).

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Emergo Asia Pacific Pty Ltd T/a Emergo Australia.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2016-RN-00224-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-03-04
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00224-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    Dexcom noticed an increase in complaints related to audible alarms and alerts associated with dexcom g4 platinum and dexcom g5 receivers.As such, all dexcom customers are being notified that that may not receive an intended audible alarm or alert. as a result, if they rely on hearing the alarm or alert, they may not detect a severe hypoglycaemic (low glucose) or hyperglycaemic (high glucose) event. this includes the fixed low alarm at 3.1 mmol/l, which alerts the user with vibration first, followed by beeps 5 minutes later if not confirmed. the vibration alert should continue to work; however, the audible beeps may not function. the vibration function for the alerts and alarm cannot be disabled by the user.
  • Action
    Emergo is providing customers with instructions on how to test the audible alarms to ensure they are functioning properly. If the alarms and alerts are not functioning, users are advised to contact the local distributor, Australasian Medical and Scientific Ltd (AMSL), for a replacement device. Dexcom is working on implementation of an improved speaker for the receivers. For more information please see https://www.tga.gov.au/alert/dexcom-continuous-glucose-monitor-receivers . This action has been closed-out on 10/05/2017.

Device

Dexcom G4 PLATINUM and Dexcom G5 Mobile receiver (Continuous Glucose Monitoring Device).

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia