Events

Alerte De Sécurité sur Accu-Chek Connect Application Technical Name: Accu-Chek Connect Application Registration Number ANVISA: Risk Class: Affected Model: Version 1.2.0, 1.2.2 and 2.0.0 (iOS and Android) Serial Numbers Affected: Required update of Accu-Chek Connect Application 1.2.0, 1.2.2, 2.0.0 (iOS and Android) to ensure correct Correction Bolus suggestion.

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
    2152
  • Date
    2017-01-05
  • 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
    If you are using versions 1.2.0, 1.2.2 or 2.0.0 of the Accu-Chek Connect application for iOS or Android, please follow the following instructions: 1) Back up your data, 2) Stop immediately 3) Download and install the latest version of the app (1.2.3 or higher) available on the Apple App Store or Play Store on Android. This will correct the problem and prevent it from occurring in the future. All other versions of the Accu-Chek Connect Application not mentioned, as well as other Accu-Chek products that use the bolus calculator, are not affected. #### 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
    We recently discovered a software problem in the accu-chek connect application versions 1.2.0, 1.2.2 and 2.0.0 that under certain conditions the history of bolus suggestions may have been affected by directly interfering with the current suggestion presented, as it may not consider the current active insulin referring to a previous bolus suggestion. another error may occur in cases where there is more than one monitor paired with the same application on the iphone (ios) operating system. in rare circumstances, after the glucose test the application may not suggest the correction bolus at the correct interval (10 to 15 minutes). depending on the patient's metabolic status, an incorrect bolus suggestion can lead to serious health problems such as hypoglycemia if the bolus suggestion function erroneously recommends a high dose of insulin. this may also cause the amount of active insulin displayed on the display to be incorrect.
  • Action
    Field Action Code SBN_RDC_2016_14 triggered under the responsibility of the company Roche Diagnóstica Brasil Ltda. Company will make correction in the field.

Device

Accu-Chek Connect Application Technical Name: Accu-Chek Connect Application Registration Number A...

Manufacturer

Roche Diagnóstica Brasil Ltda; Roche Diagnostics GmBH