Events

Rappel de Accu-Chek Connect diabetes management app

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-00007-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-01-05
  • 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-00007-1
  • 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
    Roche have identified two software issues with the accu-chek connect diabetes management app, v1.2.0, 1.2.2, 2.0.0 (ios & android). under certain conditions the affected versions may disregard historical bolus data potentially leading to an invalid bolus insulin recommendation being provided to the end user. additionally, it was discovered that pairing & using multiple meters with the ios version of the accu-chek connect app can, under rare circumstances cause the bolus advisor to fail to offer a blood glucose (bg) correction bolus recommendation within the eligible time window following a bg measurement (10 – 15 min). depending on a patient’s situation, a potentially incorrect bolus advice could lead to serious health consequences as e.G. a hypoglycaemia in case the impacted bolus advice function erroneously recommended a too high insulin dose. both issues may also cause the amount of active insulin displayed during the bolus calculation process to be incorrect.
  • Action
    Roche have released an update to the app with both issues described above corrected. In addition, Roche will be placing an alert on their website www.accu-chek.com.au informing patients to ensure they use the latest app version available on the Apple App or Google Play store (1.2.3).

Device

Accu-Chek Connect diabetes management app

Manufacturer

Roche Diabetes Care Australia Pty Ltd