Events

Alerta De Seguridad O Notificaciones De Seguridad para 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
    2019-02-19
  • Fecha de publicación del evento
    2019-02-19
  • 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-pumps-some-need-to-be-fitted-with-key-frames-to-reduce-the-risk-of-accidentally-unlocking-keys-or-pressing-the-bolus-buttons
  • 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
    The key lock function of the pump locks only the buttons on the front of the insulin pump.
    It does not lock the quick bolus keys on the top of the pump.The manufacturer has received reports of unintended boluses being delivered. Revised handling instructions were published in 2016 (MHRA issued MDA/2016/016) and now Roche Diabetes Care is providing users with key frames to fit onto all affected Accu-Check Insight pumps (i.e. pumps with serial numbers below 32100000) to further reduce the risk of accidental bolus delivery.
  • Causa
    Manufactured by roche diabetes care – important instructions on how to fit 2 separate key frames to prevent accidentally activating the pump (mda/2019/009).
  • Acción
    Identify affected patients and pumps (serial numbers below 32100000) Ensure that all patients and carers: receive a copy of manufacturer’s Field Safety Notice (FSN) and instructions for use dated December 2018 understand the information detailed in the FSN apply the new key frames as instructed by the manufacturer Return the FSN acknowledgment form to Roche as currently they have not received enough responsesThis Medical Device Alert is to ensure that all relevant organisations are aware of this FSN and encourage their patients to apply the key frames.

Device

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_2015_05_2
  • Empresa matriz del fabricante (2017)
    Roche Holding Ag
  • Source
    MHRA