Events

Alerta De Seguridad para Trade name: Etest family. Technical Name: Microorganism Identification / Antibiogram Device. ANVISA registration number: 10158120623. Class of risk: II. Affected model: Etest Polymyxin B. Serial number affected: 1002446640; 1002559300; 1002639240; 1002735070; 1002797130; 1003187220; 1003230410; 1003288010; 1003538020; 1003655420; 1003957060; 1004164300; 1004193060; 1004296350; 1004348480; 10044414690; 1004773920; 1004951670; 1005020680; 1005161530; 1005325780; 1005329410; 1005497750; 1005558710; 1005753830; 1005945380; 1002280140; 1002431510; 1002605340; 1002762220; 1002797270; 1003006080; 1003230380; 1003322180; 1003553910; 1003655460; 1003719640; 1004164310; 1004347610; 1004370570; 1004530070; 1004767110; 1004838770; 1004955950; 1005020690; 1005329420; 1005536040; 1005659460; 1005716410; 1005851010

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
    2501
  • Fecha
    2018-02-27
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 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
    Customers should be advised of nonconformity along with instructions to continue use of the impacted product with the limitation of not testing Pseudomonas and Acinetobacter strains with the Etest Polymyxin B product. Use is only recommended for Enterobacteriaceae. For tests released prior to this communication, we recommend that you identify any possible false-sensitive results that may have occurred for Pseudomonas aeruginosa and Acinetobacter in order to analyze the related risks and determine appropriate actions, if relevant. 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 option; Entity, 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
  • Causa
    Following an etest polymyxin b study with 180 clinical strains (pseudomonas aeruginosa, acinetobacter and enterobacteriaceae), an underestimation of mics was observed with etest po (versus bmd) for pseudomonas aeruginosa and acinetobacter, which led to false susceptible results when interpreted with clsi breakpoints (note: there are no breakpoints in the eucast guidelines). as a consequence, etest polimixin b can no longer be recommended for use with pseudomonas aeruginosa or acinetobacter strains.
  • Acción
    Field Action Code FSCA 3763 triggered under the responsibility of the company bioMerieux Brasil Ind e Com de Prod Laboratoriais Ltda. Orientation of the clients regarding the actions defined.

Device

Trade name: Etest family. Technical Name: Microorganism Identification / Antibiogram Device. ANVI...

Manufacturer

bioMerieux Brasil Ind e Com de Prod Laboratoriais Ltda; Biomerieux S.A