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 Siemens Healthcare Diagnostics Inc. || Jeol Ltd..

¿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
    I1511-516
  • Número del evento
    2015DM-0013005
  • Fecha
    2015-11-06
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=167
  • 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 affirms that it has identified several faults that may affect the workflow, among which are the reestablishment of the printing control, automatic archiving and erasing failed, restart of workstations, failure to communicate with the laboratory information system (lis) and re-establishment of calibration intervals, leading to the potential occurrence of incorrect calculations and adverse events due to poor sample treatment.

Device

ADVIA CHEMISTRY XPT SYSTEM
  • Modelo / Serial
    ADVIA CHEMISTRY XPT SYSTEM with software version 1.0.3
  • 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
    Siemens Healthcare Diagnostics Inc. || Jeol Ltd.

Manufacturer

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