Events

Rappel de TRUEtrack and TRUEbalance Blood Glucose Monitoring Systems

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Nipro Australia 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-01079-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-10-30
  • 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-01079-1
  • 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
    As part of nipro diagnostics internal manufacturing process blood glucose meters are required to be reconfigured to meet country specific requirements. during the reconfiguration process, the unit of measure was set incorrectly on a small subset of truebalance and truetrack meters supplied in australia. specifically, a miscalibrated meter would use mg/dl instead of mmol/l, which is the standard unit used in australia.This recall was initiated by nipro australia prior to consulting with the tga.
  • Action
    Nipro is advising users to check the serial number on the back of the meter to identify if their meter is affected. An alternative method for measuring blood glucose levels should be used if you have an affected meter. Affected meters can be returned to Nipro for a replacement unit. For more details, please see http://tga.gov.au/safety/alerts-device-nipro-glucose-meter-131031.htm .

Device

TRUEtrack and TRUEbalance Blood Glucose Monitoring Systems
  • Modèle / numéro de série
    TRUEtrack and TRUEbalance Blood Glucose Monitoring Systems
  • Manufacturer
    Nipro Australia Pty Ltd

Manufacturer

Nipro Australia Pty Ltd