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
    2017-09-20
  • Fecha de publicación del evento
    2017-09-20
  • 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-risk-of-alarm-failure
  • 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
    Due to an electrical issue there is a risk of a vibrator alarm failure and an intermittent audible alarm failure.The alarm failures will be detected during a pump’s self-test, which is prompted by changing the battery or insulin cartridge. If the failures are detected, the E7 error shows on the pump’s display.Users should contact the customer careline as instructed in the user manual if they cannot resolve an E7 error message.
  • Causa
    Manufactured by roche diabetes care – the audible and/or vibration alarms might not function, which may lead to hyperglycaemia if the user doesn’t see the notification message on the pump.
  • 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 information detailed in the FSN and follow the advice given by the manufacturer check the display of the insulin pump regularly seek clinical advice if they are concerned and have an alternative insulin therapy available if necessary contact Roche Careline to get a replacement if the pump continues to display the ‘E7’ error message Return the FSN acknowledgment form to Roche as currently the manufacturer has not received sufficient 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