Events

Rappel de Accu-Chek Mobile Blood Glucose Meter

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Roche Diagnostics Australia Pty Limited.

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-2014-RN-00592-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-05-28
  • 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-2014-RN-00592-1
  • 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
    Roche diagnostics has identified that a small number of people with diabetes using the accu-chek mobile device have experienced falsely elevated blood glucose readings when using the system as a result of not following the described and labelled handling instructions. such improper handling can include, for example, unclean hands contaminated with glucose-containing substances, pressing the finger too hard and too long on the test field or smearing the blood while performing a test. roche has decided to enhance its training and handling instructions for the accu-chek mobile system – increasing their visibility in the meter kit to ensure people with diabetes’ understanding of how to appropriately use the system. this will enable the users to obtain safe and reliable blood glucose (bg) readings at all times.Br /br /the tga has published a web statement regarding this issue. for more information, pleaser refer to: http://www.Tga.Gov.Au/safety/alerts-device-accu-chek-glucose-meter-140606.Htm.
  • Action
    Consumers are advised to continue to use their Accu-Chek Mobile device safely and reliably by carefully following the instructions that are described in the User Manual and which can also be found in a new instructions leaflet available at www.accu-chek.com.au. Specifically: · Wash your hands with warm water and soap. Dry your hands thoroughly before obtaining a blood sample. · Form a proper blood drop and apply it to the centre of the test field. · Immediately apply the blood gently to the test field after you have created the blood drop. · Do not press against the test field on the tape. · Touch the test area gently and your finger should be removed from the test field when the beep tone sounds and/or “test in progress” is displayed.

Device

Accu-Chek Mobile Blood Glucose Meter

Manufacturer

Roche Diagnostics Australia Pty Limited