Alerta De Seguridad para Accu-Chek Connect Application Technical Name: Accu-Chek Connect Application Registration Number ANVISA: 10287411061 Affected Model: Versions 2.0.0, 2.0.1, 2.1.0 (iOS & Android)

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Roche Diagnóstica Brasil Ltda.; Roche Diabetes Care GMBH.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    2251
  • Fecha
    2017-03-29
  • País del evento
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    If you use Accu-Chek Connect 2.0.0, 2.0.1, 2.1.0 (iOS & Android) versions, we request that you immediately stop using bolus calculus in those versions. We are carefully developing and testing a patched version to ensure that no such issues occur in the future. We will inform you as soon as possible as soon as this new version is available. If there is any need for further assistance on 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 - Option 2. #### Update of the field action: UPDATED ON 10/27/2017, the company presented the report of completion of the field action, with sending of necessary evidences and corrective actions.
  • Causa
    Potential inaccuracy in calculating insulin boluses in accu-chek connect application versions 2.0.0, 2.0.1, 2.1.0 (ios & android).
  • Acción
    Field Action Code SBN_RDC_2017_02 triggered under the responsibility of the company Roche Diagnóstica Brasil Ltda. Company asks you to immediately stop using bolus calculus.

Manufacturer