Events

Alerta De Seguridad O Notificaciones De Seguridad para All Accu-Chek® Insight insulin pumps

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 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
    Safety alert / Field Safety Notice
  • Fecha
    2017-05-02
  • Fecha de publicación del evento
    2017-05-02
  • País del evento
    United Kingdom
  • Fuente del evento
    MHRA
  • URL de la fuente del evento
    https://www.gov.uk//drug-device-alerts/all-accu-chek-insight-insulin-pumps-updated-information-for-battery-management
  • 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
    Note that this alert replaces and updates MDA/2015/029 which we published in August 2015.Roche has provided updated handling instructions and frequency for battery change to every 14 days from the 30 days previously recommended.
  • Causa
    Manufactured by roche diabetes care – replacement and update to mda/2015/029 with new instructions to improve battery lifetime and prevent unexpected pump shut down or rapid battery depletion.
  • Acción
    Identify all users of Accu-Chek Insight insulin pumps. Ensure that all patients and carers: Receive the manufacturer’s Field Safety Notice (FSN) understand the problem detailed in the FSN and follow the advice given by the manufacturer use Energizer® Ultimate lithium batteries (1.5V AAA / FR03) provided by the manufacturer and follow the steps described in the handling instructions in the FSN Contact Roche if you experience unexpected pump shut down or rapid battery depletion. Return the FSN acknowledgment form to Roche as currently the manufacturer hasn’t received enough responses.

Device

All Accu-Chek® Insight insulin pumps

Manufacturer

Roche Diabetes Care
  • Dirección del fabricante
    Roche Diabetes CareTel: 0800 731 2291burgesshill.insulinpumps@roche.comManufacturer FSCA Reference: SB_RDC_2017_04
  • Empresa matriz del fabricante (2017)
    Roche Holding Ag
  • Source
    MHRA