Events

Alerta De Seguridad para Preanalytical Equipment for Sample Management - ROCHE

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 Roche Diagnostics GMBH.

¿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
    I1603-86
  • Número del evento
    2015DM-0013314
  • Fecha
    2016-02-25
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=155
  • 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 he was notified of a case in which the uncovered sample tubes are not placed correctly back in the rack tube transport (rtt), the open sample tubes were found in the decapper outsorter area, contaminating the equipment with blood , the material of the tubes was spilled and could not be used to carry out the analyzes, leading to potentially adverse events on the patients and reprocesses for the analysis of the samples.

Device

Preanalytical Equipment for Sample Management - ROCHE
  • Modelo / Serial
    p512, specific serials.
  • Descripción del producto
    The preanalytic system COBAS 8100 and models p512 and p612 is a modular equipment interconnected with each other, for the processing and transport of patient samples in the clinical laboratory. The system has been designed to centrifuge the samples of the patients, remove and insert the tampons, apply the barcode labels and prepare the aliquots with the pipette from the primary samples. You can sort the samples online or off and temporarily store the samples. The system transports the different individualized samples among the cobas analytical modules for immunology, blood chemistry, hematology, hormones, drugs, urine, coagulation and special for the respective laboratory analyzes. The system does not report sample results values, it is not a sample analyzer.
  • Manufacturer
    Roche Diagnostics GMBH

Manufacturer

Roche Diagnostics GMBH