Events

Alerta De Seguridad para Cobas analyzer for blood chemistry and immunoassays

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 || Roche Diagnostics International Ltd || Roche Diagnostics Graz 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
    I1609-405
  • Número del evento
    2009DM-0003229
  • Fecha
    2016-09-27
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=120
  • 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 states that he has detected the possibility of obtaining erroneous results due to a conflict in the measurement time, obtaining the following error message "7002: a software error 108000572 has occurred", leading to delays in the analysis of the samples and possible adverse events on patients.

Device

Cobas analyzer for blood chemistry and immunoassays
  • Modelo / Serial
    COBAS C-111 SERIES, with software versions 3.0.3, 4.1.0 and 4.2.0
  • Descripción del producto
    This equipment is a continuous analyzer of random access and controlled by its software for the photometric analysis and deimmunoassays of multiple blood chemistry, immunology and electrolyte tests for low volumes of samples. It also uses the selective electrolyte ion module.
  • Manufacturer
    Roche Diagnostics Gmbh || Roche Diagnostics International Ltd || Roche Diagnostics Graz Gmbh

Manufacturer

Roche Diagnostics Gmbh || Roche Diagnostics International Ltd || Roche Diagnostics Graz Gmbh