Events

Notificaciones De Seguridad De Campo acerca de CONTOUR® DIABETES App

Según Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Slovenia que fue producido por Ascensia Diabetes Care.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Field Safety Notice
  • País del evento
    Slovenia
  • Fuente del evento
    AMPMDRS
  • Notas / Alertas
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Notas adicionales en la data
  • Causa
    We would like to inform you about a potential issue we have identified with the contour® diabetes app (version 1.2.0 or lower) when it is synchronizing data with the contour cloud. there is the potential for an isolated, very rare situation to occur where some of the data stored in the contour cloud may be incomplete. please note that this situation will only affect users using the same contour cloud account for the app on more than one mobile device (smartphone or tablet). the data on the contour® next/plus one meter and on the mobile device (“primary device”) that directly receives data from the meter are not affected, and will always show the correct and complete information including glucose values and meal markers. a health care professional report can still be generated and transmitted from the primary device (phone or tablet). if you have used the contour® diabetes app prior to version 1.2.0 in switzerland or poland this may be the second letter that you have received regarding this issue. version 1.2.0 did not completely resolve the issue. .

Device

CONTOUR® DIABETES App

Manufacturer

Ascensia Diabetes Care