Events

Alerte De Sécurité sur ADVIA Hematology System Product Name: ADVIA Hematology System Technical Name: Hematology Analyzer ANVISA Registration Number: 10345161959 Hazard Class: II Affected Model: ADVIA 560 Hematology System Affected serial numbers: S020202, S020201, S020200, S020203, S020204, S020206, S020207, S020207, S020210, S020211, S020215

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 Siemens Healthcare Diagnósticos S.A.; SIEMENS HEALTHCARE 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
    2084
  • Date
    2016-11-21
  • 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
    Customers who obtain multiple results for the same sample ID should contact their technical support representative SIEMENS to report the problem. If any of the errors are generated, the result should not be released without checking the database screen in the system, which is displayed following the recommendations of the notification letter. Siemens does not recommend a retroactive review of lab results as a consequence of this problem.
  • Cause
    Siemens detected a potential error, generating multiple results of the same sample id being generated in the database of the advia 560 hematology system, which occurred during the installation of the systems. the database must contain only one record of a sample id number for any date and time. if there are multiple records for the same sample id, it is possible that multiple results can be sent manually or automatically to the interface (lis), printed or displayed on the results report screen.
  • Action
    Field Action Code HI 17-02 triggered under the responsibility of the company Siemens Healthcare Diagnósticos SA Company will send notification to the client.

Device

ADVIA Hematology System Product Name: ADVIA Hematology System Technical Name: Hematology Analyzer...

Manufacturer

Siemens Healthcare Diagnósticos S.A.; SIEMENS HEALTHCARE DIAGNOSTICS INC
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    ANVSANVISA