Events

Rappel de Accu-Chek Mobile Blood Glucose Monitoring System

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 Diagnostics Australia Pty Limited.

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-2014-RN-00438-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-04-17
  • 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-2014-RN-00438-1
  • 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 diabetes care has become aware of a limitation of accu-chek mobile glucose tests, which may lead to erroneously lowered blood glucose readings in patients undergoing ceftriaxone therapy. this antibiotic substance is used to treat a variety of infections such as respiratory infections or lower urinary tract infections and is only administered intravenously or intramuscularly. the interference is due to the effect of this antibiotic on the measuring system of the device. this limitation is not described in the product labelling.
  • Action
    Roche Diabetes Care is advising users of this issue and update to the device's labelling. Patients with diabetes who are receiving therapy with ceftriaxone could be using the affected blood glucose monitoring (bGM) system. If this is the case then Roche is recommending customers to obtain an alternative bGM system for the duration of this therapy. For more details, please see http://www.tga.gov.au/safety/alerts-device-accu-chek-mobile-140422.htm .

Device

Accu-Chek Mobile Blood Glucose Monitoring System

Manufacturer

Roche Diagnostics Australia Pty Limited