Events

Alerta De Seguridad para ADVIA CHEMISTRY XPT SYSTEM

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 Jeol Ltd. || 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
    I1608-319
  • Número del evento
    2015DM-0013005
  • Fecha
    2016-08-02
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=128
  • 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
    The manufacturer reports that it has detected the possibility of a software error that may alter the result obtained by the analyzer for the calculation of hemoglobin, leading to possible adverse events on the patients.

Device

ADVIA CHEMISTRY XPT SYSTEM
  • Modelo / Serial
  • Descripción del producto
    The ADVIA CHEMISTRY XPT SYSTEM instrument is an automated analyzer for clinical chemistry or blood chemistry tests that processes tests in serum, plasma, urine or cerebrospinal fluid in random access mode and by series with a production rate of 1800 pho- totometric tests per hour and 600 tests of electrolytes (ISE) by now. Performs colorimetry, enzymatic, puntofinal, kinetic, selective ion for electrolytes. Of continuous random access. Uses urine, serum or plasma samples for in vitro diagnostic tests (IVD) of enzymes, biochemistry, cardiovascular, oncology, anemia, electrolytes, etc. It is in automated system that reports the values of the tests and communicates the results of clinical of the patient.
  • Manufacturer
    Jeol Ltd. || Siemens Healthcare Diagnostics Inc.

Manufacturer

Jeol Ltd. || Siemens Healthcare Diagnostics Inc.
  • Source
    NIDFSINVIMA