Events

Rappel de One Touch Verio IQ Blood Glucose Monitoring System

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Johnson & Johnson Medical 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-00243-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-03-27
  • 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-2013-RN-00243-1
  • 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
    At extremely high blood glucose levels of 56.8 mmol/l and above, the onetouch verio iq meter will turn off instead of displaying the message "extreme high glucose above 33.3 mmol/l" as intended. on restart the meter will enter set up mode.
  • Action
    Patients are advised to continue using their OneTouch Verio IQ meter until the replacement meter arrives. However, if the meter unexpectedly turns off and enters set-up mode after turning it back on, the patient should contact their Diabetes Nurse Educator or Health Professional as this may be an indication of extremely high blood glucose. Distributors and health services are being advised to immediately return all affected product.

Device

One Touch Verio IQ Blood Glucose Monitoring System
  • Modèle / numéro de série
    One Touch Verio IQ Blood Glucose Monitoring SystemProduct Code: 02258801ARTG Number: 200176
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd

Manufacturer

Johnson & Johnson Medical Pty Ltd