Events

Safety Alert for G4 PLATINUM and Dexcom G5 Mobile receiver

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by DexCom Incorporated..

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2016-03-09
  • Event Date Posted
    2016-03-09
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160309b.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: dexcom g4 platinum and dexcom g5 mobile receiver the therapeutic goods administration (tga) of australia has posted a medical device safety alert concerning dexcom g4 platinum and dexcom g5 mobile receiver manufactured by dexcom incorporated. [part number: mt20649-2 and mt22719-2]. the manufacturer has noticed an increase in complaints related to audible alarms and alerts associated with dexcom g4 platinum and dexcom g5 receivers while monitoring product complaints through their quality management system. the manufacturer is notifying all affected customers that they 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. the manufacturer is providing users with instructions on how to test the audible alarms to ensure they are functioning properly. according to the local supplier, dexcom g4 platinum is distributed in hong kong but not dexcom g5 mobile receiver. for details, please refer to the tga website: http://apps.Tga.Gov.Au/prod/sara/arn-detail.Aspx?k=rc-2016-rn-00224-1 if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 9 march 2016.

Device

G4 PLATINUM and Dexcom G5 Mobile receiver
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Dexcom G4 PLATINUM and Dexcom G5 Mobile receiver
  • Manufacturer
    DexCom Incorporated.

Manufacturer

DexCom Incorporated.