Events

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

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Emergo Asia Pacific Pty Ltd T/a Emergo Australia.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2016-RN-00224-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-03-04
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00224-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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