Alerta De Seguridad para Trade name: Vidas 3 Technical name: Lives 3 ANVISA registration number: 10158120679 Hazard class: I Affected name: Not applicable

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por bioMérieux Brasil Indústria e Comércio de Produtos Laboratoriais Ltda.; bioMérieux S.A..

¿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
    1.1- "Error code 0550CAPU1" displayed in case of tip loss does not suggest the appropriate error solution. Required Actions: In case of error message "error 0550 risk of contamination", associated with loss of tip during sample aspiration: - Do not follow the instructions provided by the instrument. - Call bioMérieux right away. - The System must be decontaminated by the Engineering Service of bioMérieux before use. 1.2- For customers using automatic pipetting mode: "error code 0400FAPU1" not justified. Actions Required: Check if sample volume is above dead volume (indicated in user manual): - If there is not enough sample, error 400 is justified and there is no impact. Follow the instructions provided by the instrument. - If there is a sufficient sample, please apply the following actions: - Stop using the machine in automatic mode, and use only the manual pipetting mode. - Discard all processed loaded tubes at the same time as the affected sample. - Conduct a retrospective analysis of the results of these samples, including those sent to the LIS. - Call bioMérieux. 1.3- Stopping the section during the analytical phase may induce the falling of the bar inside the apparatus. Actions Required: When a section is stopped for any reason (section stop, door open, alarms or power failure) during the analytical phase, please decontaminate the pipetting block and the tray of the barrels following the decontamination procedure described in the user guide. (SPR® Block Cleaning and Section Barrier Tray Cleaning). We also recommend that you avoid stopping a section during the analytical phase (stop button or door opening during the test). 1.4- Only for customers who manage their internal or external Quality Control via VIDAS®3 Quality Control Module. Required Actions: We recommend that you avoid modification of name, full name and / or level of Quality Control. Actions Required from the administrative point of view of the laboratory: - Please distribute this information to all appropriate personnel in your laboratory, keep a copy in your files and send this information to all parties who may use this product, including others to whom you may have sent / downloaded our product. - Apply the necessary actions described above and associated with each described limitation. - Discuss any questions you may have regarding previously reported results with your Laboratory Medical Officer to determine the course of action required. - Fill out and return the Acknowledgment Form in Appendix A to confirm receipt of this notice. ### Field Action Update: UPDATED ON 10/25/2017, the company submitted the field action completion report verifying the submission of the customer safety warning with evidence from science and all actions completed.
  • Causa
    During the development of version 1.2 of the software used in the vidas3 equipment, some anomalies were identified and observed that already exist in the current version of the software in use in the field, version 1.1.4. among the identified func- tioning anomalies, 04 of them may be potentially occurring with customers in brazil. the anomaly related to the operation of the equipment when in conjunction with the vidas lyme igg kit does not apply to brazil because we do not have this kit registered in the country and therefore we do not market it. the anomaly related to countries where there is winter time, as to the operation of the equipment, does not apply to brazil either. anomalies that may occur in equipment installed in brazil. 1.1- "error code 0550capu1" displayed in case of loss of tip in the equipment, does not suggest the appropriate error solution. this anomaly concerns the risk of contamination of reagents / samples or the system, and may lead to a possible impact on patient outcomes. 1.2- for customers who use the automatic pipetting mode: "error code 0400fapu1" appears unjustified. this anomaly refers to a risk of contamination of samples that can be recharged in other instruments, and may lead to a possible impact on patient outcome. if the system fails to detect the liquid level while there is liquid in the tube, error 400 will occur and will be visible on the loading map. 1.3 - stopping the section during the analytical phase may induce the falling of the bar inside the apparatus. this anomaly refers to a risk of contamination of the client and / or instrument, which can lead to a possible impact on the results of the next patients. 1.4 - only for customers who manage their control.
  • Acción
    Field Action Code FSCA 3134 triggered under the responsibility of bioMérieux Brasil Indústria e Comércio de Produtos Laboratorias Ltda.