Events

Rappel de Accu-Chek Connect diabetes management app – Bolus Advisor function

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

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-2017-RN-00410-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-03-29
  • 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-2017-RN-00410-1
  • 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
    A software issue has been identified in the accu-chek connect diabetes management app versions 2.0.0, 2.0.1, and 2.1.0 (ios & android). under certain conditions, the affected app versions may cause the bolus advisor to reset and display an incorrect active insulin amount of 0.0 on the app’s home screen, which may lead to an incorrect bolus advice. no warning message is displayed to the user. depending on the individual patient’s metabolic situation, a potentially incorrect bolus advice could result in serious health consequences (e.G. hypoglycaemia). (please note that previous versions of the app are not affected by this software issue. no other roche product with a bolus advisor is affected. also, all other functions on the accu-chek connect app can still be used.).
  • Action
    Roche Diabetes Care is requesting healthcare professionals to notify their patients to whom the Accu-Chek Connect diabetes management app bolus advisor has been prescribed, and advise them to discontinue using the bolus advisor function. Roche is advising users that an updated version is being developed and they will be informed once it is available. Consumers with the affected app versions are advised to liaise with their healthcare professional for further advice.

Device

Accu-Chek Connect diabetes management app – Bolus Advisor function
  • Modèle / numéro de série
    Accu-Chek Connect diabetes management app – Bolus Advisor function Versions 2.0.0, 2.0.1, 2.1.0 (iOS & Android)ARTG Number: 224385
  • Manufacturer
    Roche Diabetes Care Australia Pty Ltd

Manufacturer

Roche Diabetes Care Australia Pty Ltd