Events

Alerta De Seguridad para Cobas b 123 Fluid Pack 200 and Cobas b 123 Fluid Pack 400, Registration No. 10287410927; Cobas b 123 Fluid Pack COOX 200, Cobas b 123 Fluid Pack COOX 400 and Cobas b 123 Fluid Pack COOX 700, Registration No. 10287410931. Lots involved Annex 1

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Roche Diagnóstica Brasil Ltda.; 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
    1654
  • Fecha
    2015-07-20
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
  • Notas adicionales en la data
    The company clarifies how the QC results may be low average values, but still within 2 standard deviations (SD), there is a potential risk of erroneously generating low PO2 results in patient samples, especially in blood samples, in values ​​below 50 mmHg of PO2. The company further reports that to date, there are no known cases where this issue caused any serious adverse events for patients.
  • Causa
    Roche diagnostics gmbh, a legal manufacturer of the products involved in this notification, after complaints and internal investigations, has identified changes in qc (values ​​of cq below target values) of the po2 parameter in the cobas b 123 poc systems caused by a calibration problem with the parameter po2 in specific batches of cobas b 123 fluid pack (200 and 400 tests) and cobas b 123 fluid pack coox (200, 400 and 700 tests).
  • Acción
    Actions to be taken by the customer / user The company recommends that: - For the affected batches of cobas b 123 Fluid Pack listed in Table 1 currently in use, the PO2 parameter must be deactivated in the equipment. Requests that the detailed workaround presented in Appendix 1 to the Customer Letter (Annex 2) be followed. - Cobas b 123 Fluid Packs from affected batches not yet in use can be disposed of on site. - Replacement of affected lots may be requested from Roche Diagnóstica Brasil Ltda. The company notes that not all drives have this error, but for security reasons, requests that they not use the affected batches listed with the PO2 parameter enabled. Distribution map - Annex 3

Device

Cobas b 123 Fluid Pack 200 and Cobas b 123 Fluid Pack 400, Registration No. 10287410927; Cobas b ...

Manufacturer

Roche Diagnóstica Brasil Ltda.; Roche Diagnostics GmBH