Events

Rappel de NordiPen used with 5mg, 10mg and 15mg Norditropin SimpleXx cartridgesLot numbers beginning with A, B or CARTG Number: 124725

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Novo Nordisk Pharmaceuticals Pty 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-2013-RN-00650-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-07-04
  • 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-2013-RN-00650-1
  • 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
    Internal investigations have concluded that a component supplier change led to a minor change in the shape of the metal thread which joins the mechanical section to the cartridge holder. as a result, the metal thread on the mechanical section is more likely to cut into the plastic thread inside the cartridge holder resulting in increased resistance during assembly. increased resistance during assembly can result in a patient assuming a pen is correctly assembled when it is not, which could result in under dosing.
  • Action
    Novo Nordisk are providing health care professionals and consumers with clarified instructions for the assembly of the Nordipen. For more details, please see http://www.tga.gov.au/safety/alerts-device-nordipen-130723.htm

Device

NordiPen used with 5mg, 10mg and 15mg Norditropin SimpleXx cartridgesLot numbers beginning with A...
  • Modèle / numéro de série
    NordiPen used with 5mg, 10mg and 15mg Norditropin SimpleXx cartridgesLot numbers beginning with A, B or CARTG Number: 124725
  • Manufacturer
    Novo Nordisk Pharmaceuticals Pty Ltd

Manufacturer

Novo Nordisk Pharmaceuticals Pty Ltd