Events

Rappel de Animas 2020 and Animas IR 1200 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 Australasian Medical & Scientific 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-2015-RN-00363-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2015-05-18
  • 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-2015-RN-00363-1
  • 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
    Animas has identified a software limitation included in the animas 2020 and animas 1200 insulin pumps. the software included in the animas 2020 insulin pump only operates until midnight on dec. 31, 2015. after this date, the pump will no longer deliver insulin and will generate a call service alarm. this end of use date is not currently included in our product labelling. the calendar software included in the animas 1200 will not recognise and store any date in 2016 or beyond. after midnight on dec. 31, 2015, the pumps’ calendars will revert to a previous year. this calendar issue is not currently included in our product labelling. although these pump models will continue to deliver insulin, if patients are using a data management software program with their pump, they will notice inaccuracies in the reports because of the incorrect dates.
  • Action
    AMSL is replacing 2020 and IR 1200 pumps which are still in use with a new model Aminas Vibe Insulin Pump. This action has been closed-out on 24/08/2016.

Device

Animas 2020 and Animas IR 1200 Insulin Pumps

Manufacturer

Australasian Medical & Scientific Ltd