Events

Notificaciones De Seguridad De Campo acerca de Glucofacts Deluxe

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 an issue we have identified with the latest version of glucofacts deluxe (3.10.07) when it is receiving insulin and carbohydrate values from the contour®next/plus one meter that were manually entered into the contour® diabetes app. please note that this issue only affects users of glucofacts deluxe version 3.10.07 who are using it with the contour®next/plus one meter and have entered insulin and carbohydrate values in the contour® diabetes app. if you are using a contour®next/plus one meter without the app or using any other contour® meter, you are not affected and can use glucofacts deluxe without any limitations. blood glucose measurements transferred from all contour® meters, including contour®next/plus one, are also unaffected. .

Device

Glucofacts Deluxe

Manufacturer

Ascensia Diabetes Care