Events

Alerte De Sécurité sur 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

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par Roche Diagnóstica Brasil Ltda.; Roche Diagnostics GmBH.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    1654
  • Date
    2015-07-20
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    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.
  • Cause
    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).
  • Action
    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