Events

Alerte De Sécurité sur 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

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par bioMerieux Brasil Ind e Com de Prod Laboratoriais Ltda; Biomerieux S.A.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    2501
  • Date
    2018-02-27
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    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
  • Cause
    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.
  • Action
    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