Events

Alerte De Sécurité sur Product 1. BCS SYSTEM, registration 10345161639, risk class I, batches affected: 321208; 361922; 251626; 290672W; 161762. /// Product 2. BCS XP SYSTEM, registry 10345161642, risk class I, batches affected: 311502; 280727; 280800; 301266; 301267; 280775; 221651; 331848; 442036.

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 Ltda.; 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
    1595
  • Date
    2015-05-21
  • 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
    According to the manufacturer the health risk is related to the possibility of inappropriate classification, for higher values, of Factor IX, for results of patients in the lower reading range. It is important to know that hemophilia B is characterized by the deficiency of Factor IX coagulation activity that results in prolongation of bleeding after injury, dental extractions or surgeries, and recurrent delay or bleeding before complete wound healing.
  • Cause
    Release of erroneously high results for factor ix with the application protocols of the bcs and bcs xp systems at the lower limit of the measurement range.
  • Action
    The registry holder will change protocols for the implementation of the Factor IX Define test. In addition, it is advised to discontinue use of the "Factor IX with Pathromtin SL [34]" application protocol and instead use the "Factor IX with Pathromtin SL [463]" application protocol; discontinue the use of extrapolation for reading values ​​at lower levels of the "Factor IX with Pathromtin SL [463]" application protocol and "Factor IX with Actin [467]" application protocol. Do not report patient results below 30% F IX for application protocols "Factor IX with Actin FSL [471]".

Device

Product 1. BCS SYSTEM, registration 10345161639, risk class I, batches affected: 321208; 361922; ...

Manufacturer

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