Events

Alerte De Sécurité sur G4 PLATINUM and Dexcom G5 Mobile receiver

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par DexCom Incorporated..

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2016-03-09
  • Date de publication de l'événement
    2016-03-09
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160309b.html
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    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
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Dexcom G4 PLATINUM and Dexcom G5 Mobile receiver
  • Manufacturer
    DexCom Incorporated.

Manufacturer

DexCom Incorporated.