Events

Alerta De Seguridad para COBAS B-123 POC SYSTEM analyzer

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
    I1609-371
  • Número del evento
    2011DM-0007372
  • Fecha
    2016-09-02
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=123
  • 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 it has detected the possibility of obtaining a measurement of low results in the total labilirubin value in samples of neonates analyzed by the referenced medical devices, leading to the presentation of possible adverse events on the patients.

Device

COBAS B-123 POC SYSTEM analyzer
  • Modelo / Serial
    Cobas b123, specific serials.
  • Descripción del producto
    The COBAS B-123 POC SYSTEM analyzer <1, 2, 3 and 4> is an automated device for the quantitative determination of Ph, arterial gases and electrolytes by leaving in whole blood, serum, plasma or urine. It also performs debicarbonate, lactate, GLUCOS HCT and HB tests, depending on the final configuration of the instrument from VR1 to VR4. It is an automated system that reports the values of the tests and communicates the results of the patient's clinics. The instrument can be used in the critical care units (POINT-CARE) or in the clinical laboratory. The reagents used with the COBAS B-123 POC SYSTEM DE ROCHE analyzer system have respective health records.
  • Manufacturer
    Roche Diagnostics Gmbh || Roche Diagnostics International Ltd. || Roche Diagnostics Graz Gmbh

Manufacturer

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