Events

Rappel de CONTOUR NEXT control solutions. In vitro diagnostic medical device (IVD). MiniMed Paradigm insulin infusion pumps, MiniMed NGP Pumps, MiniMed Guardian Monitor REAL-Time and CONTOUR NEXT test strips.

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Bayer Australia 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-00746-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2015-08-27
  • 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-00746-1
  • 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
    Contour next control solutions. in vitro diagnostic medical device (ivd)contournext control solutions are used with contour next test strips andcontournext family meters (contour xt/next ez, contour next, contour next link, contour next link 2.4, contour next usb), medtronic minimed paradigm insulin infusion pumps, minimed ngp pumps medtronic minimed guardian monitor real-time . all lots of control solution are affectedartg number: 191635.
  • Action
    Bayer is notifying healthcare professionals of changes to the instructions for use. The additional instructions provide detailed information on the proper handling of Contour Next controls. Bayer is also notifying health care professionals that if a CONTOUR NEXT control test result is outside of the control range, make sure to follow the instructions above, and perform another control test.

Device

CONTOUR NEXT control solutions. In vitro diagnostic medical device (IVD). MiniMed Paradigm insuli...
  • Modèle / numéro de série
    CONTOUR NEXT control solutions. In vitro diagnostic medical device (IVD).MiniMed Paradigm insulin infusion pumps (MMT- 512, MMT-712, MMT-515, MMT-715, MMT-522, MMT-522K, MMT-722, MMT-722K, MMT- 523, MMT523K, MMT-723, MMT-723K, MMT-551, MMT-751, MMT-554 and MMT-754), MiniMed NGP Pumps (MMT-1510, MMT-1511, MMT-1512, MMT-1580, & MMT- 1712), MiniMed Guardian Monitor REAL-Time (CSS7100 & CSS7200) and CONTOUR NEXT test strips. All lots of control solution are affected.
  • Manufacturer
    Bayer Australia Ltd

Manufacturer

Bayer Australia Ltd
  • Société-mère du fabricant (2017)
    Bayer AG
  • Source
    DHTGA