Events

Alerta De Seguridad para Trade name: Etest Cefuroxima Technical name: Etest family (Etest Cefuroxima): 100 strips (foam) and individual presentation 30 strips (single pack). ANVISA Registration Number: 10158120623 Hazard Class: II Model Affected: N / A Serial Numbers Affected: Reference 412305: Lot 1004497810 / Reference 506918: Lot 1004022170.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Olympus Optical do Brasil Ltda.; Olympus Medical Systems Corp..

¿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
    2202
  • Fecha
    2017-02-20
  • 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
    Biomerieux will forward Letter to all clients containing all the guidelines. Recommendations for CLSI 2016 users only. Labs may continue to use the Etest Cefuroxime product (single pack and foam presentations) and may release the results for Streptococcus pneumoniae and Enterobacteriaeceae when oral cut-off points are used when applying the recommendations, as described in the Letter to the Client. For the tests previously performed, Biomérieux requests that it identify any possible false-sensitive results, analyze the related risks and determine appropriate actions, if relevant. Contact your Biomerieux representative for product compensation. Complete the Confirmation Form (Attachment A), forwarded with the Letter to the Client, and return to Biomérieux. #### Update of the field action: UPDATED ON 07/28/2017, the company presented the completion report of the field action proving the sending of the safety notice to the client.
  • Causa
    An analysis was performed on the essential agreement rate reflecting the mic result obtained by the product for strains of relevance, including enterobacteriaceae, haemophilus and s. pneumoniae species. an additional analysis was then performed for clinical categorization of strains based on the clsi guideline. the investigation revealed a potential problem for the categorization of strains of streptococcus pneumoniae and enterobacteriaceae limited to oral cefuroxime cutoff points and based only on clinical clsi 2016 standards. for steptococcus pneumonia with etest cefuroxime foam and single pack that could lead to a minor error in clinical strains: false-sensitive result rather than intermediate results with bmd reference method (broth microdilution); false intermediate result rather than resistant result with reference method bmd (broth microdilution). for enterobacteriaceae: false-sensitive result rather than intermediate results with reference method ad (dilution in agar); false intermediate result rather than resistant results with ad (agar dilution agar) reference method. product performance is within specification when interpreted with eucast 2016 guidelines.
  • Acción
    Field Action Code FSCA 3303 triggered under the responsibility of the company Biomerieux Brasil Ind Comercio de Produtos Laboratoriais Ltda. Company will update, correct or supplement the instructions for use.

Device

Trade name: Etest Cefuroxima Technical name: Etest family (Etest Cefuroxima): 100 strips (foam) a...

Manufacturer

Olympus Optical do Brasil Ltda.; Olympus Medical Systems Corp.