Events

Alerte De Sécurité sur Accu-Chek Connect Application (iOS) Technical Name: Accu-Chek Connect Application (iOS) Registration Number ANVISA: 10287411061 Hazard Class: Model Affected: Version 1.2.0 for iOS

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par Roche Diagnóstica Brasil Ltda; Roche Diagnostics GmBH.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    2148
  • Date
    2016-09-22
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
  • Notes supplémentaires dans les données
    Actions to be taken by the user: Required update of Accu-Chek Connect Application iOS 1.2.0 for iOS to ensure correct Correction Bolus suggestion. If you are using version 1.2.0 of the Accu-Chek Connect application for iOS, please follow the following instructions: 1) Back up data 2) Immediately stop using version 1.2.0 3) Download and install the latest version of the application (greater than 1.2.0) available from the Apple App Store. If there is any need for further assistance with the operation of the Accu-Chek Connect system or in cases of doubt, please do not hesitate to contact our Accu-Chek Response Center at 0800 77 20 126. ### # UPDATED ON 11/21/2017, the company presented the report of completion of the field action, with sending of necessary evidences and corrective actions.
  • Cause
    The accu-chek performa connect blood glucose monitoring system is designed for the quantitative measurement of glucose in capillary blood and is an aid to monitor the effectiveness of blood glucose control. the control results are stored in memory, but can not be checked in the blood glucose monitor. if you need to view the stored control results, you need to transfer them to a compatible software application. the accu-chek connect application is an accessory part of the accu-chek performa connect product, which can be optionally used by the user. roche diabetes care gmbh, the legal manufacturer of the product involved in this notification, after internal investigations identified a software problem in the accu-chek connect application version 1.2.0 (accessory part of the accu-chek performa connect product) only in the ios operating system, that under certain conditions, the lamp icon is displayed and may suggest an incorrect correction bolus. also in some cases, the lamp icon in the application is not displayed and the suggestion for bolus correction is not available. therefore, roche diagnostica brasil informs users of the accu-chek connect application to immediately update to the latest version of the accu-chek connect application that can be found on the apple app store (version greater than 1.2.0). roche diagnóstica brasil has not yet received any adverse event complaint related to this issue.
  • Action
    Field Action Code SBN_RDC_2016_12 triggered under the responsibility of the company Roche Diagnóstica Brasil Ltda. Company will make correction in Field.

Device

Accu-Chek Connect Application (iOS) Technical Name: Accu-Chek Connect Application (iOS) Registrat...

Manufacturer

Roche Diagnóstica Brasil Ltda; Roche Diagnostics GmBH