Notificaciones De Seguridad De Campo acerca de Optium Xceed meters manufactured by Abbott Diabetes Care; Boots brand meters; OneTouch Ultra test strips manufactured by LifeScan

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

¿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
  • Fecha
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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 optium xceed blood glucose meter (manufactured by abbott diabetes care) or boots brand blood glucose meters, may generate incorrect results when used in conjunction with the onetouch ultra test strips, manufactured by lifescan.
  • Acción
    The IMB recommends that users follow the manufacturer’s instructions for use and User’s Guide to determine which blood glucose meters and test strips are compatible.  Table showing compatible meters and test strips  Manufacturer Meter Compatible test strip Abbott Diabetes Care Optium Xceed Optium Plus test strips (foil wrapped) Boots Boots Brand Optium Plus test strips (foil wrapped) LifeScan OneTouch Ultra OneTouch Ultra 2 OneTouch UltraEasy OneTouch UltraSmart OneTouch Ultra test strips Pharmacists supplying OneTouch Ultra test strips and Optium Xceed or Boots brand meters:  If you supply Optium Xceed or Boots brand meters you should advise the user to only use Optium Plus test strips. When you dispense OneTouch Ultra test strips you should advise the user that these test strips are only intended for use with the OneTouch Ultra brand meters.   GPs prescribing blood glucose meter test strips: Only prescribe Optium Plus test strips for use with Optium Xceed or Boots brand meters.  Only prescribe OneTouch Ultra test strips for use with OneTouch Ultra brand meters.  Healthcare professionals managing patients who use the affected devices:   Advise patients to ensure that they are using the correct test strips for their meter as described in the meter’s user manual.     Healthcare professionals who use these devices:  Ensure that Optium Plus test strips are only used with the Optium Xceed or Boots brand meters. Ensure that OneTouch Ultra test strips are only used with the OneTouch Ultra brand meters. General public:  Only use Optium Plus test strips with the Optium Xceed or Boots brand meters. Only use OneTouch Ultra test strips with OneTouch Ultra brand meters. Please bring this safety notice to the attention of all who need to be aware of it. This will include further distribution to:  Accident & Emergency Departments  All wards  Ambulance services directors  Ambulance staff  Biochemists  Chief pharmacists  Clinical pathologists  Clinical pathology directors  Day surgery units  Diabetes clinics / outpatients  Diabetes nurse specialists  Hospital pharmacists  Medical Directors  Nursing executive directors  Outpatient clinics  Outpatient theatre managers  Outpatients theatre nurses  Pharmacists  Point of care testing co-ordinators  Risk managers  The IMB has also published an Information leaflet on safety tips for blood glucose meters. Please see the Information leaflets section on the Publications page of the website.


  • Modelo / Serial
  • Descripción del producto
    Blood Glucose Meters and Test Strips 23.10.2009
  • Manufacturer


  • Source