Alerta De Seguridad para Trade name: VIDAS - Automated System for the Execution of Laboratory Diagnostic Tests. Technical name: Instrument for immunoassays. ANVISA registration number: 10158120241. Risk class: I. Model affected: LIVES / miniVIDAS System / VIDAS / miniVIDAS system. Serial number affected: This field action is not a dependent batch.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por bioMerieux Brasil Ind e Com de Prod Laboratoriais Ltda.; Biomerieux 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
    The following actions will be implemented to reduce the number of false results identified after a QCV alert: - Systematic pump cleaning every year during preventive maintenance, - Systematic replacement of VIDAS® / mini VIDAS® pumps over 7 years old, - Remember the instrument user's guide instructions for customers at the end of a race: check the presence of the color-coded point in the SPR®, - increase the frequency of QCV tests made by the customer to weekly (previously monthly). If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link Additional information: - Date of identification of the problem by the company: 04/01/2018 - Date of notification notice to Anvisa: 02/01/2018 The company that owns the affected product is responsible for contacting its customers in due time. to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "
  • Causa
    Life / minvice pipetting failures, which include pump clogging and spr® displacement encoded by colored (dot) labels. an abnormality in the aspiration or dispensing steps performed by the pump (particularly due to pump obstruction) can affect the sample volume of the pipetted patient or other solutions transferred to the withdrawal wells. because a decrease in volume can induce an impact on the biological test result, the qcv test is designed to detect pump problems and alert the user before a biological test result is affected. the qcv frequency and alert threshold have been set to allow the system to detect progressive obstruction. when a qcv is outside its acceptable range, it means that the system is not able to vacuum properly within the specifications. the various aspiration steps may be affected by the issue and may affect the results.
  • Acción
    Field Action Code FSCA 3749 triggered under the responsibility of the company bioMerieux Brasil Ind e Com de Prod Laboratoriais Ltda.