Events

Alerte De Sécurité sur Trade Name: AUTOMATIC BLOOD COAGULATION ANALYSIS SYSTEM Technical Name: Coagulation Parameters Determination Device ANVISA Registration Number: 0345161778; 10345161920 Hazard Class: II Affected Model: CS-2100i; CS-5100 Serial numbers affected: All serial numbers.

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 Products 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
    2167
  • Date
    2017-02-10
  • 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
    Clients using the INNOVANCE D-Dimer assay on the CS-Series blood coagulation analyzer (CS-2100i, CS-5100) should change the limit of the minimum extrapolation value within the INNOVANCE D-Dimer setting and the calibration must be according to the concentration of the calibrator to the new threshold.
  • Cause
    Siemens healthcare diagnostics has confirmed that in very rare circumstances a false negative result for the innovance d-dimer assay can be reported by cs-series automatic blood clotting analysis systems (cs-2100i, cs-5100) if the initial result is falsely flagged with an antigen excess error that triggers automatic re-reading at 1/19 dilution and the raw rerun signal is less than the method's white limit (lob). under such conditions, re-reading of low values ​​may be strongly affected by the signal noise of the optical system and may generate an erratically low optical gross value. this gross value will be corrected by the dilution factor and can be deduced from the calibration curve in a false low range.
  • Action
    Field Action Code PH 17-006 triggered under the responsibility of the company Siemens Healthcare Diagnósticos SA Company will make letter to the client.

Device

Trade Name: AUTOMATIC BLOOD COAGULATION ANALYSIS SYSTEM Technical Name: Coagulation Parameters De...

Manufacturer

Siemens Healthcare Diagnósticos S.A; Siemens Healthcare Diagnostics Products GmbH.
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    ANVSANVISA