Events

Notificaciones De Seguridad De Campo acerca de GlucoMen LX Sensor blood glucose test strips 50 count (product code 38877), used with the GlucoMen LX and GlucoMen LX PLUS meter

Según Health Products Regulatory Authority, este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Ireland que fue producido por A. Menarini Diagnostics S.r.l..

¿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
    SN2013(09)
  • Fecha
    2013-08-20
  • 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=/glucomen-lx-sensor-blood-glucose-test-strips-50-count-(product-code-38877)-used-with-the-glucomen-lx-and-glucomen-lx-plus-meter&id=a996f825-9782-6eee-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
    The irish medicines board (imb) has been notified that certain lots of glucomen lx sensor blood glucose test strips have been subject to a manufacturing fault and may give erroneously high blood glucose results, potentially leading to inappropriate insulin administration.
  • Acción
    Advice for End Users / Patients:  1. Identify, discontinue use and quarantine devices from the affected lot.  2. Return any devices from the affected lot to your pharmacy or distributor. Alternatively, contact A. Menarini Diagnostics (UK) or Medicon Ireland to arrange for return of any devices from the affected lot.  3. Ensure that you can continue to appropriately monitor your blood glucose via test strips from a different lot number or by other means. This should be done in consultation with your healthcare professional.  Advice for Healthcare Professionals / Pharmacists / Distributors:  1. Identify, discontinue distribution and quarantine devices from the affected lot.  2. Return any devices from the affected lot to your distributor. Alternatively, contact A. Menarini Diagnostics (UK) or Medicon Ireland to arrange for return of any devices from the affected lot.  3. Please also pass this notice on to any end user or organisation where the potentially affected devices have been transferred or who are using the GlucoMen LX and GlucoMen LX PLUS meters.  4. Ensure that the appropriate personnel and end users are made aware of this notice.  5. Ensure that end users who return blood glucose test strips from the affected lots can continue to appropriately monitor their blood glucose.

Device

GlucoMen LX Sensor blood glucose test strips 50 count (product code 38877), used with the GlucoMe...
  • Modelo / Serial
  • Descripción del producto
    GlucoMen LX Sensor blood glucose test strips 50 count (product code 38877), used with the GlucoMen LX and GlucoMen LX PLUS meter
  • Manufacturer
    A. Menarini Diagnostics S.r.l.

Manufacturer

A. Menarini Diagnostics S.r.l.