Events

Notificaciones De Seguridad De Campo acerca de Accu-Chek Spirit Combo insulin pump (Pumps with serial numbers in the range 10171897 to 10281629 inclusive)

Según Health Products Regulatory Authority, este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Ireland que fue producido por Roche Diagnostics Ltd..

¿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
    Field Safety Notice
  • Número del evento
    SN2014(13)
  • Fecha
    2014-03-24
  • País del evento
    Ireland
  • Fuente del evento
    HPRA
  • URL de la fuente del evento
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/accu-chek-spirit-combo-insulin-pump-(pumps-with-serial-numbers-in-the-range-10171897-to-10281629-inclusive)&id=52cdf925-9782-6eee-9b55-ff00008c97d0
  • Notas / Alertas
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland."
  • Notas adicionales en la data
  • Causa
    There is an increased risk that, due to a component change, vibration alarm defects may cause an ‘e-7’ alert message. this fault will be detected at pump start up, when it will display an ‘e-7’ error message and give an audible signal, but will fail to start. the other pump alarms – visual and audible - are not affected by this issue. pumps with serial numbers in the range 10171897 to 10281629 (inclusive) are potentially affected. these pumps were distributed to the irish market between late 2010 and early 2012 and to date, no ‘e-7’ issues related to vibration alarm defects have been reported from ireland.
  • Acción
    1. Identify affected pumps.  2. If a delay to insulin therapy could compromise patient safety, consider using an alternative device.  3. When using these pumps:  • Ensure that users are aware of the problem  • Ensure that users have a syringe or insulin pen available in case the pump stops  • If the pump displays an ‘E-7’ error, contact Roche for a replacement device  4. Ensure that appropriate personnel are made aware of this notice. Please also pass this notice on to any end user or organisation where the potentially affected insulin pumps have been transferred

Device

Accu-Chek Spirit Combo insulin pump (Pumps with serial numbers in the range 10171897 to 10281629 ...
  • Modelo / Serial
  • Descripción del producto
    Accu-Chek Spirit Combo insulin pump (Pumps with serial numbers in the range 10171897 to 10281629 inclusive)
  • Manufacturer
    Roche Diagnostics Ltd.

Manufacturer

Roche Diagnostics Ltd.