Events

Alerte De Sécurité sur CHEMICAL SYSTEM VITROS 5,1 FUSION - Codes 6801375/6801890/6801890, Record no. 80145900827, lots: See Annex 1 - Distribution list.

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 Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda; ORTHO CLINICAL DIAGNOSTICS, INC..

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
    1675
  • Date
    2015-08-27
  • 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 informs that if this anomaly occurs, the VITROS® 5.1 FS System can process samples using the factory default report units that exist in the ADD, instead of the parameters modified by the user (ie SI vs. Conventional units) . The company also informs that it has identified that the root cause of this anomaly is an error in the software code. The resolution is currently under development and will be available in the future version of the software.
  • Cause
    The company received 2 customer complaints about events that occurred during the installation of an add. the following two situations have been reported: 1. when the customer installed the add compatible with the new vitros® chemistry products hba1c reagent kit, the vitros® 5.1 fs system reported the following 2 condition codes (ua7-239 and syd-024 ): the investigation detected that the condition codes occurred because the abbreviated test name of the new vitros® test had the same abbreviated test name as the user defined assay currently in use on its vitros® 5.1 system fs. as a result, the destination of user defined assay has been deleted from the system. 2. when a customer installed the add, the system did not respond (freeze / screen lock), causing the vitros® 5.1 fs system to restart; the system reported a condition code (uz0-047) after the system restarts. - for the 2 software coding error situations, all the default settings were restored from the add, instead of keeping the parameters modified by the user (configured), and the operator was not alerted by the system.
  • Action
    The company advises that: • Before installing an ADD compatible with a new test, make sure that the new test does not have the same name as another UDA currently on your system. If the names are the same, you will need to: 1. Rename the UDA with a name that is different from the VITROS® short test name 2. Install the ADD. More information in Annex 2 - Communication to customers

Device

CHEMICAL SYSTEM VITROS 5,1 FUSION - Codes 6801375/6801890/6801890, Record no. 80145900827, lots: ...

Manufacturer

Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda; ORTHO CLINICAL DIAGNOSTICS, INC.