Alerta De Seguridad para Trade name: FilmArray BCID Panel. Technical name: Combined parameters in the same product. ANVISA registration number: 10158120695. Class of risk: III. Model Affected: Not applicable. Lots / series numbers affected: 538617/538517/545518

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.; Biofire Diagnostics, LLC.

¿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
    If the product is used to test the BACTEC BDBC blood glucose bottles due on or after September 30, 2018, the results for Proteus should be confirmed by another method before reporting the test results. Customers will be guided by the company, via an alert message, regarding the performance of tests by alternative methodology in cases of positive results for Proteus. The BD bottles with which the problem was identified are linked to the following references: 442020 BD BACTEC ™ Peds Plus ™ / F culture Vials (Plastic), 442021 BD BACTEC ™ Lytic / 10 Anaerobic / F culture Vials, 442023 BD BACTEC ™ Plus Aerobic / F Culture Vials, 442192 BD BACTEC ™ Plus Aerobic / F Culture Vials and 442265 BD BACTEC ™ Lytic / 10 Anaerobic / F Culture Vials. It is not known if subsequent lots of medium will also be subject to this risk. BioFire and BD (manufacturers) continue to investigate the problem. The most likely cause for this risk is the presence of an increased level of nucleic acid from non-viable Proteus in BD BACTEC ™ Hemoculture Vials. False positive results for Proteus were observed when testing a few batches of blood culture medium prior to inoculation with the patient sample. The company BioFire has confirmed the presence of Proteus nucleic acid in several batches of media affected using an independent PCR / bidirectional sequencing method. The presence of non-viable microorganisms does not compromise the intended function of blood culture bottles (culture of viable microorganisms). However, the FilmArray BCID Panel detects the nucleic acid of viable and non-viable microorganisms. False positives observed are typically seen as positive multiples with the FilmArray BCID Panel because a positive culture is a prerequisite for a BCID test. 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: 03/19/2018 - Date of notification notice to Anvisa: 03/04/2018 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
    An increased risk of false positive proteus results was identified when the filmarray bcid panel product is used with bactec ™ bd hemoculture bottles, with expiration dates of september 30, 2018 and october 31, 2018.
  • Acción
    Field Action Code FSCA 3822 triggered under the responsibility of the company Biomérieux Brasil Indústria e Comércio de Produtos Laboratoriais Ltda. Orientation to clients according to letter to be sent.