Events

Alerta De Seguridad para Trade Name: AUTOMATIC BLOOD COAGULATION ANALYSIS SYSTEM Technical Name: Coagulation Parameters Determination Device ANVISA Registration Number: 0345161778; 10345161920 Hazard Class: II Affected Model: CS-2100i; CS-5100 Serial numbers affected: All serial numbers.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Siemens Healthcare Diagnósticos S.A; Siemens Healthcare Diagnostics Products GmbH..

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    2167
  • Fecha
    2017-02-10
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
  • Notas adicionales en la data
    Clients using the INNOVANCE D-Dimer assay on the CS-Series blood coagulation analyzer (CS-2100i, CS-5100) should change the limit of the minimum extrapolation value within the INNOVANCE D-Dimer setting and the calibration must be according to the concentration of the calibrator to the new threshold.
  • Causa
    Siemens healthcare diagnostics has confirmed that in very rare circumstances a false negative result for the innovance d-dimer assay can be reported by cs-series automatic blood clotting analysis systems (cs-2100i, cs-5100) if the initial result is falsely flagged with an antigen excess error that triggers automatic re-reading at 1/19 dilution and the raw rerun signal is less than the method's white limit (lob). under such conditions, re-reading of low values ​​may be strongly affected by the signal noise of the optical system and may generate an erratically low optical gross value. this gross value will be corrected by the dilution factor and can be deduced from the calibration curve in a false low range.
  • Acción
    Field Action Code PH 17-006 triggered under the responsibility of the company Siemens Healthcare Diagnósticos SA Company will make letter to the client.

Device

Trade Name: AUTOMATIC BLOOD COAGULATION ANALYSIS SYSTEM Technical Name: Coagulation Parameters De...

Manufacturer

Siemens Healthcare Diagnósticos S.A; Siemens Healthcare Diagnostics Products GmbH.
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    ANVSANVISA