Events

Notificaciones De Seguridad De Campo acerca de Hemoglobin A1c_3 (A1c_3 and A1c_3M) Reagent Lots

Según Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Slovenia que fue producido por Siemens Healthcare Diagnostics Inc..

¿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
  • País del evento
    Slovenia
  • Fuente del evento
    AMPMDRS
  • Notas / Alertas
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Notas adicionales en la data
  • Causa
    Siemens healthcare diagnostics has confirmed the hemoglobin a1c_3/ a1c_3m reagent kit lots listed in table 1 used on the advia® 1200, 1650, 1800, 2400, and xpt chemistry systems may demonstrate an increased occurrence of high %hba1c bias. siemens internal investigation demonstrates reagent lots 230 and 231 may exhibit a positive bias averaging 0.6% hba1c units, ranging from -0.1% to 1.1% hba1c units. the bias was observed when comparing %hba1c means to ngsp pooled patient target-value assigned samples ranging from approximately 5.5% to 8.0% hba1c. the maximum bias was observed at higher %hba1c concentrations. qc samples may exhibit a similar bias. .

Device

Hemoglobin A1c_3 (A1c_3 and A1c_3M) Reagent Lots
  • Modelo / Serial
    Lot Number Hemoglobin A1c_3 (160 test kit) A1c_3, A1c_3M 10379673 10379673 230 Hemoglobin A1c (800 test kit) A1c_3, A1c_3M 10485591 10485591 230 Hemoglobin A1c (800 test kit) A1c_3, A1c_3M 10485591 10485591 231
  • Manufacturer
    Siemens Healthcare Diagnostics Inc.

Manufacturer

Siemens Healthcare Diagnostics Inc.
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    AMPMDRS