Events

Rappel de NovoPen Echo

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-2017-RN-00832-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-07-10
  • 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-2017-RN-00832-1
  • 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
    Novo nordisk a/s has detected that the insulin cartridge holder used in a small number of novopen echo batches may crack or break after exposure to certain chemicals, in particular, certain cleaning agents. using a novopen echo insulin cartridge holder that is cracked or broken could result in the device delivering a smaller dose of insulin than expected, which can lead to serious health consequences including hyperglycaemia (high blood sugar).There are no reported problems with the insulin being administered by these devices and that cracking and breaking should not occur if the device is cleaned in accordance with the instructions in the user guide. the risk of patients experiencing problems as a result of this issue is considered extremely low.
  • Action
    Patients: Where affected pens have been issued to a patient, Novo Nordisk urges patients to replace the cartridge holder, as some could be damaged (as per User Guide). Register your contact details (name, address, phone number, email and number of affected cartridge holders) either at www.novonordisk.com.au or www.novonordisk.com/novopenecho5.html in order to receive a replacement cartridge holder for your NovoPen Echo (after 7 working days, approximately). Health Care professionals: Please immediately quarantine all affected batches within your possession to prevent further distribution. Complete and return the Acknowledgment form even if no affected stock is held. Whenever the opportunity presents, please reiterate to patients that the cleaning instructions of the NovoPen Echo User Guide (page 26) describe that a cloth dampened ONLY with water (and certainly not with bleaching agents such as chlorine, iodine or alcohol) is to be used to clean the insulin pen.

Device

NovoPen Echo
  • Modèle / numéro de série
    NovoPen EchoBatch Numbers (as shown on NovePen Echo Carton): EVG3310-6, EVG4252-2, EVG4253-2, FVG8218-4, FVG8412-3 and FVG8415-1Batch Numbers (as shown on NovePen Echo Pen): EVG3310, EVG4252, EVG4253, FVG8218, FVG8412 and FVG8415ARTG Number: 189785
  • Manufacturer
    Novo Nordisk Pharmaceuticals Pty Ltd

Manufacturer

Novo Nordisk Pharmaceuticals Pty Ltd