Events

Avis De Sécurité sur cobas c 111 analyzer

Selon Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Slovenia qui a été fabriqué par Roche.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Field Safety Notice
  • Pays de l'événement
    Slovenia
  • Source de l'événement
    AMPMDRS
  • Notes / Alertes
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Notes supplémentaires dans les données
  • Cause
    We have become aware of a software issue that may lead to erroneous results on cobas c 111 analyzer (without ise unit) in very rare cases. cobas c 111 analyzer with ise unit are not affected as long as the ise is in status ‘ready’. to date, no field issue has been reported where the identified software error actually produced wrong results. under very rare constellations of already used and unused cuvettes remaining on the cobas c 111 analyzer rotor a measurement timing error “7002: 108000572 a software error occurred” might be produced. immediately after occurrence of the error all ongoing tests are stopped. depending on open test orders the system might restart processing using an already consumed cuvette and hence, producing a potentially erroneous result. we have identified measures to ensure the detectability for measurements that may have yielded erroneous results. .

Device

cobas c 111 analyzer
  • Modèle / numéro de série
  • Manufacturer
    Roche

Manufacturer

Roche