Events

Alerta De Seguridad O Notificaciones De Seguridad para Lifescan OneTouch Verio Pro, Lifescan OneTouch Verio IQ

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 manufacturer #17429.

¿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/2013/022
  • Número del evento
    CON261794
  • Fecha
    2013-04-11
  • Fecha de publicación del evento
    2013-04-11
  • 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/CON261794?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
    Recall of one touch verio meters because of a software fault at glucose levels of 56.8mmol/l and above. one touch verio pro: at very high blood glucose concentrations a falsely low result will be displayed. one touch verio iq: at very high blood glucose concentrations no result will be displayed. lifescan has notified the mhra of a software problem affecting the one touch verio pro and one touch verio iq blood glucose meters. onetouch verio pro: displays an incorrect result and stores this incorrect result in the memory. at extremely high blood glucose levels (56.8mmol/l and above), the incorrect result will be 56.8mmol/l lower than the measured result. onetouch verio iq: no result will be displayed, and no result will be stored in the memory. at extremely high blood glucose levels (56.8mmol/l and above), the meter will countdown then turn off instead of displaying a result. lifescan is recalling all onetouch verio blood glucose meters manufactured up to the 07 march 2013 and has written to patients and relevant healthcare professionals i.E. diabetes specialist nurses, gps, practice nurses and pharmacists. one touch verio pro and one touch verio iq meters are capable of reporting results in the range 1.1 – 33.3mmol/l. the performance of the test strips is not affected by this problem. this problem also affects the onetouch verio pro+ device, which is used by health professionals only. lifescan has issued a field safety notice concerning this to all affected customers. this problem does not affect any other blood glucose meter supplied by lifescan.
  • Acción
    Advise users of affected meters to contact Lifescan customer services on 0800 279 9118. Pharmacists supplying OneTouch Verio meters or OneTouch Verio test strips: Do not supply any affected OneTouch Verio meters. If you have any affected OneTouch Verio meters in your current stock contact LifeScan customer care for replacements. When dispensing OneTouch Verio test strips advise users with affected meters to contact LifeScan customer care for a replacement meter, and provide a copy of the relevant customer letter (see appendix). Healthcare professionals who manage patients who use OneTouch Verio meters: Identify patients who are using affected meters. Advise users of affected meters to contact LifeScan customer care for a free replacement. Pharmacists supplying these devices or OneTouch Verio test strips. Healthcare professionals who manage patients who use these devices.

Device

Lifescan OneTouch Verio Pro, Lifescan OneTouch Verio IQ
  • Modelo / Serial
  • Descripción del producto
    Home use blood glucose meters: Lifescan OneTouch Verio Pro Lifescan OneTouch Verio IQ Lifescan OneTouch Verio Pro meters with serial numbers beginning RA, RB, RC, RD and RE have been recalled.  Replacement meters have serial numbers beginning RF. The serial number can be found on the back of the meter itself. Lifescan OneTouch Verio IQ meters with serial numbers beginning TA and TB have been recalled.  Replacement meters have serial numbers beginning TC. The serial number can be found on the back of the meter itself.
  • Manufacturer
    manufacturer #17429

Manufacturer

manufacturer #17429