Events

Alerta De Seguridad O Notificaciones De Seguridad para Accu-Chek® Insight Insulin pump system

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
    2016-09-01
  • Fecha de publicación del evento
    2016-09-01
  • País del evento
    United Kingdom
  • Fuente del evento
    MHRA
  • URL de la fuente del evento
    https://www.gov.uk//drug-device-alerts/accu-chek-insight-insulin-pump-system-risk-of-over-or-under-infusion-of-insulin
  • 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
    Manufactured by roche diabetes care - inadequately detailed handling instructions of the 'key lock' function of the pump may lead to unintentional operation, which could result in rapid and severe deterioration of health e.G. hypoglycaemia or diabetic ketoacidosis.
  • Acción
    Identify users of the Accu-Chek Insight insulin pump system. Healthcare professionals should ensure that: patients/carers understand that the Quick Bolus keys on the top of the Accu-Chek Insight insulin pump are NOT locked by the Key Lock function patients/carers receive a copy of manufacturer’s Field Safety Notice (FSN), and are made aware of the enhanced handling instructions all new patients/carers have a copy of the FSN with their Accu-Chek Insight pump system. GPs should note that this is for their information only.

Device

Accu-Chek® Insight Insulin pump system

Manufacturer

Roche Diabetes Care
  • Dirección del fabricante
    Roche Diabetes Care Accu-Chek Pump Care Line Telephone: 0800 731 22 91Email: burgesshill.insulinpumps@roche.comManufacturer FSCA Reference: SB_RDC_2015_05
  • Empresa matriz del fabricante (2017)
    Roche Holding Ag
  • Source
    MHRA