Events

Alerta De Seguridad para Advia blood chemistry 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 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
    I1401-8
  • Número del evento
    2008DM-0002852
  • Fecha
    2014-01-14
  • 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 in the references of the aforementioned medical device that make use of the software versions v2.00, v2.01, v3.52, v4.01, the error "/////" may be displayed at the time of can not calculate a result or when the concentration of a sample is outside the absorbance limit values, which can lead to erroneous interpretations of the results obtained.

Device

Advia blood chemistry analyzer
  • Modelo / Serial
    ADVIA 1200, ADVIA 1650
  • Descripción del producto
    This equipment is an automated analyzer for blood chemistry tests by colorimetry, enzymatic, endpoint, kinetics, selective ion for continuous random access electrolytes. Uses urine, serum or plasma samples for in vitro diagnostic tests of enzymes, biochemistry, cardiovascular, oncology, anemia, electrolytes, etc. It is an automated system that reports the values of the tests and communicates the clinical results of the patient.
  • Manufacturer
    Siemens Healthcare Diagnostics Inc.

Manufacturer

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