Events

Rappel de Accu-Chek Connect Diabetes Management App for iPhone (iOS) v1.2.0(.5) (used in conjunction with Roche Accu-Chek Avica Connect and Accu-Chek Guide Blood Glucose Meters).

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 Diabetes Care 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-2016-RN-01168-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2016-09-07
  • 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-2016-RN-01168-1
  • 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 diabetes care has identified a programming error in the accu-chek connect diabetes management app ios version 1.2.0(.5) which under certain conditions could potentially lead to an inaccurate bolus insulin advice being provided to the patients. as a result of this issue the app “lightbulb” icon is not displayed and the correction bolus advice is not available.. the blood glucose (bg) value which could not be used initially may unintentionally become available for bolus advice calculation at a later time. if the patients then request a bolus advice for a bg value older than 10 minutes without taking and transferring a new bg measurement, it could lead to an incorrect bolus insulin recommendation. depending on the actual metabolic situation a potentially incorrect bolus advice could lead to serious health consequences.
  • Action
    Roche is advising Health Care Professionals to inform their patients by distributing a copy of the letter, to whom the Accu-Chek Connect diabetes management app has been distributed. Patients are being advised to discontinue using version 1.2.0.5 and update their app immediately to version 1.2.2.2. This action has been closed-out on 12/05/2017.

Device

Accu-Chek Connect Diabetes Management App for iPhone (iOS) v1.2.0(.5) (used in conjunction with R...

Manufacturer

Roche Diabetes Care Australia Pty Ltd