Events

Alerta De Seguridad para ADVIA 560 and 360 HEMATOLOGY 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 Diatron Mi Plc || 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
    I1604-176
  • Número del evento
    2015DM-0013266
  • Fecha
    2016-04-29
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=144
  • 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 has identified that after its use erroneous results can be obtained, since they do not indicate the following flag: the warning flag for low sample volumes (w) and the flags of morphology that indicate the presence of immature granulocytes (g) and atypical lymphocytes (g) , which could lead to potentially adverse events on patients due to diagnostic errors.

Device

ADVIA 560 and 360 HEMATOLOGY SYSTEM
  • Modelo / Serial
    ADVIA 560, serial S020202, S020201, S020200 and S020197, with software version 4.1.2133
  • Descripción del producto
    The ADVIA 560 and 360 HEMATOLOGY SYSTEM are a fully automated, high-quality hematology system for use in in vitro diagnostics in clinical laboratories. The system uses the impedance method for the measurement of deleucocyte concentrations (WBC), erythrocytes (RBC) and platelets (PLT). The concentration of hemoglobin (HGB) of the red blood cells semide by photometric refraction. The system provides a differential measurement of the WBC 5-part leukocyte formula (LYM%, MON%, NEU%, EOS%, BAS%) by laser-based optical flow cytometry technology. The ADVIA 560 and the ADVIA 360 HEMATOLOGY SYSTEM identify patients with hematological parameters within and outside the established reference ranges. The system can process up to 100 ul of whole blood that is agicoagulated, automatically for hematology.
  • Manufacturer
    Diatron Mi Plc || Siemens Healthcare Diagnostics Inc

Manufacturer

Diatron Mi Plc || Siemens Healthcare Diagnostics Inc
  • Source
    NIDFSINVIMA