Events

Alerta De Seguridad O Notificaciones De Seguridad para GlucoMen LX Sensor blood glucose test strips 50 count used with the GlucoMen LX and GlucoMen LX PLUS meter

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 Menarini.

¿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
  • ID del evento
    MDA/2013/064
  • Número del evento
    CON303150
  • Fecha
    2013-08-14
  • Fecha de publicación del evento
    2013-08-14
  • País del evento
    United Kingdom
  • Fuente del evento
    MHRA
  • URL de la fuente del evento
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON303150?tabName=allTabs
  • 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
    Affected lots have been contaminated during manufacture, and may give an overestimation of blood glucose levels, potentially resulting in inappropriate insulin administration. the manufacturer distributed the affected lots in the uk via wholesale outlets during october and november 2012. the product may, however, still remain with users or pharmacies. there is currently no evidence that uk patients have been affected.
  • Acción
    Identify and quarantine affected lots. Identify patients using these meters and advise them that they should return and not use strips from the affected lots. Ensure that users who return strips from the affected lots can continue to monitor their blood glucose. Contact Menarini to arrange the return of any strips from the affected lots.

Device

GlucoMen LX Sensor blood glucose test strips 50 count used with the GlucoMen LX and GlucoMen LX P...
  • Modelo / Serial
  • Descripción del producto
    Home use blood glucose test strips GlucoMen LX Sensor blood glucose test strips 50 count (product code 38877), used with the GlucoMen LX and GlucoMen LX PLUS meter manufactured by Menarini. Lot 3212214249, expiry date 31-08-2014 and lot 3212219249, expiry date 31-08-2014. Illustration of tub, containing 50 test strips.
  • Manufacturer
    Menarini

Manufacturer

Menarini