Alerta De Seguridad para Trade name: Xpert EV. Technical Name: Enterovirus. ANVISA registration number: 81062710013. Risk class: II. Affected model: Kit with 10 tests (cartridges with integrated reaction tubes). Affected serial numbers: 1000045409 / cartridge batch 06802

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por CEPHEID BRASIL IMPORTAÇÃO, EXPORTAÇÃO E COMÉRCIO DE PRODUTOS DE DIGANÓSTICOS LTDA.; CEPHEID.

¿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 proposed action to address device failures is to send customers a Field Security Notification, which informs customers to stop using the Xpert EV product, lot 1000045409/06802, which will later be collected by the company. According to the Instructions for Use, users should repeat the test with an extra specimen. 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 Complementary Information: - Date of identification of the problem by the company: 09/26/2017 - Date of notification notice to Anvisa: 10/11/2017 The company that owns the affected product is responsible for contacting its customers in a timely manner. 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
    There has been a high invalid result rate and low probe verification failures (e5007) by customers when using xpert ev lot 1000045409/06802. field data from customers who were receiving invalid errors were evaluated. the invalid error rate was considered to be 13% (228 total tests). additionally during data analysis, a failure rate of 15% of e5007 faults was found. - internal test of this lot resulted in 4 error of detection of loss of signal (sld) of 210 cartridges tested. the lot was manufactured with an open cartridge lot which showed a change from the initial valve value of the cartridge integrity test of the valve body compared to other batches manufactured in the same period. the change found indicated that the valve bodies used to manufacture the open cartridge batch potentially exhibited weak retention of the valve body pressure.
  • Acción
    Field Action CPHD-003/2017 Code triggered under the responsibility of the company Cepheid Brazil Import, Export and Trade of Products of Diganósticos Ltda. It will make recollection.