Events

Alerta De Seguridad para ADVIA Hematology System Product Name: ADVIA Hematology System Technical Name: Hematology Analyzer ANVISA Registration Number: 10345161959 Hazard Class: II Affected Model: ADVIA 560 Hematology System Affected serial numbers: S020202, S020201, S020200, S020203, S020204, S020206, S020207, S020207, S020210, S020211, S020215

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 INC.

¿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
    2084
  • Fecha
    2016-11-21
  • 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
    Customers who obtain multiple results for the same sample ID should contact their technical support representative SIEMENS to report the problem. If any of the errors are generated, the result should not be released without checking the database screen in the system, which is displayed following the recommendations of the notification letter. Siemens does not recommend a retroactive review of lab results as a consequence of this problem.
  • Causa
    Siemens detected a potential error, generating multiple results of the same sample id being generated in the database of the advia 560 hematology system, which occurred during the installation of the systems. the database must contain only one record of a sample id number for any date and time. if there are multiple records for the same sample id, it is possible that multiple results can be sent manually or automatically to the interface (lis), printed or displayed on the results report screen.
  • Acción
    Field Action Code HI 17-02 triggered under the responsibility of the company Siemens Healthcare Diagnósticos SA Company will send notification to the client.

Device

ADVIA Hematology System Product Name: ADVIA Hematology System Technical Name: Hematology Analyzer...

Manufacturer

Siemens Healthcare Diagnósticos S.A.; SIEMENS HEALTHCARE DIAGNOSTICS INC
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    ANVSANVISA