Events

Notificaciones De Seguridad De Campo acerca de Accu-Chek® Compact test strips

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.

¿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(18)
  • Fecha
    2014-04-17
  • 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-compact-test-strips.-priority-2---warning&id=b5cff925-9782-6eee-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
    Roche diabetes care has become aware of a limitation of accu-chek® compact test strips and accu-chek® mobile tests, which may lead to erroneously lowered blood glucose readings in patients undergoing ceftriaxone therapy (e.G. rocephin® or cefotrix®). this limitation is not described in the product labelling.
  • Acción
    The IMB advises that users:  (1) Determine whether you receive therapies containing the antibiotic substance ceftriaxone.  (2) Do not use Accu-Chek® Compact test strips or Accu-Chek® Mobile tests throughout the duration of treatment with ceftriaxone.  (3) Ensure that you can continue to monitor your blood glucose appropriately. This should be done in consultation with your healthcare professional.  The IMB advises that healthcare professionals:  (1) Identify all patients who receive therapies containing the antibiotic substance ceftriaxone.  (2) Advise these patients not to use Accu-Chek® Compact test strips or Accu-Chek® Mobile tests throughout the duration of treatment with ceftriaxone.  (3) Ensure that these patients can continue to monitor their blood glucose appropriately by providing an alternative blood glucose monitoring system.  (4) Ensure that the appropriate personnel are made aware of this notice and the attached FSN. Please pass this Safety Notice and the attached FSN on to any end users or organisations where Accu-Chek® Compact Plus and Accu-Chek® Mobile systems may have been distributed.

Device

Accu-Chek® Compact test strips
  • Modelo / Serial
  • Descripción del producto
    Accu-Chek® Compact test strips. Priority 2 - Warning
  • Manufacturer
    Roche Diagnostics

Manufacturer

Roche Diagnostics