Events

Rappel de Accu-Chek Spirit Combo insulin pump

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-00576-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-05-30
  • 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-00576-1
  • 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
    There is an increased risk that the vibration alarm will not work, as a result of a changed component. this fault will only be detected at pump start up, when it will display an ‘e-7’ error message and give an audible signal, but will fail to start. safety features such as the continuing audio signal as well as a visual notification will enable the user to detect the issue immediately and thus prevent from using an incorrectly functioning device.Br /br /the tga has published a web statement regarding this issue. for more information, please refer the following link: http://www.Tga.Gov.Au/safety/alerts-device-accu-chek-insulin-pump-140606.Htm.
  • Action
    Roche is advising Accu-Chek Spirit Combo users of the potential for frequent E7 errors and reinforcing the instructions on how to clear the error. If the E7 error occurs repeatedly users are requested to contact Roche for a replacement device. This action has been closed-out on 10/02/2016.

Device

Accu-Chek Spirit Combo insulin pump

Manufacturer

Roche Diagnostics Australia Pty Limited