Events

Alerta De Seguridad para Trade Name: BCS XP System / ANVISA Registry: 10345161642 / Hazard Class: I / Model: BCS XP System / Serial No.: 211651; 280800; 280775; 331848; 311502; 301266; 301267; 280727 and 442036.///// BCS SYSTEM, registry Anvisa: 10345161639, serial number: 321208; 361922; 290672W

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
    1795
  • Fecha
    2016-01-13
  • 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
    In conditions where an interferent is present, there is a potential risk of prolonged prothrombin time loss. In most of these cases, the patient is intensively monitored or has apparent clinical condition. False clotting time was observed in intensive care patient samples.
  • Causa
    False short and unlabeled clotting time for tp assay with dade innovin reagent run on bcs and bcs xp systems.
  • Acción
    Sending alert letter. CN code PH 16-003. Risk classification III (situation in which there is a low probability that the use or exposure to a health product may have adverse health consequences). Recommendation to users and patients: Attention should be paid to interfering levels (such as hemolysis and jaundice), since false coagulation time may be due to these conditions. An irregular reaction can be visually identified by the outcome curve. Siemens is working on an advanced algorithm to identify the curves and after finalizing the validation activities the alorithm in question will be implemented.

Device

Trade Name: BCS XP System / ANVISA Registry: 10345161642 / Hazard Class: I / Model: BCS XP System...

Manufacturer

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