Alerta De Seguridad para ENGEN LABORATORY AUTOMATION SYSTEM ENGEN LABORATORY AUTOMATION SYSTEM ANVISA Registration Number: 80145901089 Hazard Class: I Affected Model: ENGEN LABORATORY AUTOMATION SYSTEM Affected Batch / Serial Numbers: Series - Engen

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda; THERMO FISHER SCIENTIFIC OY.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
  • Fecha
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    A Tag Read fault in the VITROS Bypass suction position (STOPPER_DEVIATOR) is one of the events required for this problem to occur. Tag Read failures are not common and indicate that Sample ID information for the sample can not be read. To identify a Tag Read Fault event that may indicate that the problem has occurred, do the following: • On the TCA controller, check the "Show All Messages" screen (Select MessagesMMore¿ Show All Messages ) to see if the Error ID 525 associated with the VITROS System message and the Workstation Error Details message showing "STOPPER_DEVIATOR" appears. (See "Error Illustrations 525" on Page 3). Ortho recommends that this check be performed at least during daily maintenance. • If you only identify an Error ID 525 associated with a VITROS System and Workstation Error Details showing "STOPPER_DEVIATOR": o Contact the Ortho Care ™ Technical Support Center immediately for assistance in determining whether the problem it occurred. NOTE: Ortho has a limited ability to determine if the problem occurred on your system before the date of the oldest backup file on the system (the default is 30 days). Talk to your Lab Medical Director about any questions regarding previously reported results to determine the appropriate course of action. o Until instructed otherwise by Ortho Care, do not put samples on the rail for sorting or routing. Place the samples directly into the analyzer. • Complete and return the Receipt Confirmation form.
  • Causa
    This urgent product correction notification sent by ortho clinical diagnostics (ortho) is about a software anomaly in which the tcautomation software can send incorrect information to a vitros system through the inout communication interface; this event may cause an unintended sample to be moved to the bypass aspiration position and aspirated, and the results will be erroneously associated with the patient sample id without the operator being notified. the inout communication interface is currently used by all engen systems. ortho did not detect a real occurrence of this problem, nor did it report an occurrence on any engen system. however, one incident was detected in a vitros bypass supported by another company. important notice: if this problem occurs, all subsequent samples in the bypass module may have results that will be erroneously associated with patient sample ids until the tca software automatically clears the bypass queue or bypass is manually restarted or turned off.
  • Acción
    Field Action Code TC2017-059 triggered under the responsibility of Johnson & Johnson do Brasil Ind. And Com. De Prod. for Health Ltda. Company will make correction in the field.