Events

Alerta De Seguridad O Notificaciones De Seguridad para Accu-Chek Mobile meter and Accu-Chek Mobile test cassette

Según Medicines and Healthcare products Regulatory Agency, este evento ( alerta de seguridad o notificaciones de seguridad ) involucró a un dispositivo médico en United Kingdom que fue producido por Roche.

¿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
    Safety alert / Field Safety Notice
  • ID del evento
    MDA/2014/021
  • Número del evento
    CON425103
  • País del evento
    United Kingdom
  • Fuente del evento
    MHRA
  • URL de la fuente del evento
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON425103?tabName=allTabs
  • Notas / Alertas
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • Notas adicionales en la data
  • Causa
    This device may give falsely high readings. as a consequence, patients might take an inappropriately high dose of insulin. the meter uses strip-free technology so users need to follow a specific testing procedure that is different to standard meter and strip systems. roche has sent its field safety notice (fsn), with updated instructions, to registered patients, healthcare professionals, distributors and retailers. the instructions are also online: www.Accu-chek.Co.Uk/mobilepropertesting (external link) this meter has been distributed in the uk since 2010.
  • Acción
    Identify patients who use these meters and advise them to follow the correct testing procedure, details of which have been provided in the FSN. Ensure that patients can continue to monitor their blood glucose. If patients are concerned about their blood glucose readings when using this meter, advise them to contact their healthcare professional.

Device

Accu-Chek Mobile meter and Accu-Chek Mobile test cassette
  • Modelo / Serial
  • Descripción del producto
    Home use blood glucose meters. Accu-Chek Mobile meter and Accu-Chek Mobile test cassette manufactured by Roche.
  • Manufacturer
    Roche

Manufacturer

Roche