Events

Alerta De Seguridad para automatic blood coagulation analyzer

Según National Institute of Drugs and Food Surveillance (INVIMA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Colombia que fue producido por Sysmex Corporation.

¿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
    I1401-6
  • Número del evento
    2010DM-0005612
  • Fecha
    2014-01-08
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=212
  • Notas / Alertas
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • Notas adicionales en la data
  • Causa
    It was stated by the manufacturer that some faults associated with the medical device software may be present during the processing of the sample, generating erroneous outputs of the determined values, which may lead to inaccurate values being presented in the patient's test results.

Device

automatic blood coagulation analyzer
  • Modelo / Serial
    CS-2100I, CS-2000I
  • Descripción del producto
    The coagulation analyzers CS2000I / CS2100I are fully automated instruments for quantitative coagulation, immunological and chromogenic coagulation tests. Continuous random access. Uses deplasma samples for in-vitro diagnostic (IVD) assays of PT, APTT, TT, fibrinogen, D-Dimero; AT-III; PLG; PC and individual factors I to XIII. It is an automated system that reports the values of the tests and communicates the clinical results of the patient. The reagents that are used with the SYSEX®CS2000I / CS2100I devices have respective health records.
  • Manufacturer
    Sysmex Corporation

Manufacturer

Sysmex Corporation
  • Empresa matriz del fabricante (2017)
    Sysmex Corp.
  • Source
    NIDFSINVIMA