Events

Rappel de Accu-Chek Spirit Combo Insulin Pumps

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-01063-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-10-01
  • 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-01063-1
  • 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 that in a limited number of cases, patients using the accu-chek spirit combo insulin pump may experience a loss of the date and time settings. investigations undertaken by roche revealed that this issue may occur if the pump capacitor fails to function properly due to a leakage. the capacitor provides the necessary voltage to save time and date settings during power interruption, typically during a battery change.
  • Action
    Roche is advising end users and healthcare professionals of the potential issue. End users are advised to ensure that the time and date are set correctly after a battery change. Users who experience any failures are requested contact the Accu-Chek Customer Care Line to arrange for a replacement pump. For more details, please see http://www.tga.gov.au/safety/alerts-device-accu-chek-insulin-pump-141003.htm This action has been closed-out on 18/08/2016.

Device

Accu-Chek Spirit Combo Insulin Pumps

Manufacturer

Roche Diagnostics Australia Pty Limited