Events

Alerte De Sécurité sur EthEST COLISTINE Technical Name: Etest COLISTINE Registration Number ANVISA: 10158120623 Hazard Class: II Model Affected: Serial Numbers Affected: Reference 537300: Lots 1004832200, 1004432930, 1004329220, 1004190730, 1004171220, 1003969990, 1003890030, 1003767080, 1003767080, 1003725600 , 1003610660, 1003532330, 1003514310, 1003514810, 1003514810, 1003409509, 1003409509, 1003297790,, 1003409509, 1002796090, 1002780680, 1002594030, 1002517610, 1002438560, 1002336190, 1002154530, 1001742150, 100144200, 1001416080, 1001260560, 1001158900, 1000941970, 1000893880, 1000756330, 1000714690. Reference 537308 : Lots 1004752310, 1004576760, 1003767090, 1003616140, 1003456440, 1003403320, 1002989530, 1002889130, 1002795210, 1002703940, 1002523000, 1002343060, 1001744750,

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 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
    2070
  • Date
    2017-01-03
  • 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
    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 . ### Update of the field action: UPDATED ON 10/25/2017, the company presented the report of completion of the field action proving the sending of the security warning to the client with evidence of science and all actions completed.
  • Cause
    Based on the scientific publications (including eucat on its website) on gradient tests and colistin diffusion discs, including e-test (ref .: 537300 and 37308), biomérieux was warned of a potential underestimation of mic values ​​for enterobacteriaceae and acinetobacter. biomérieux began an investigation to confirm the performance of the product and determine the root cause. the following data were identified and corrected by fsca 3061, previously forwarded on 10/8/2016. 1- the performance of e-test colistin co 256 depending on the mueller hinton medium plate used as described in supplement (ref. 16266, dress a) - ciso012. 2 - for enterobacteriaceae strains, the first results of our investigations establish that the performance of the e-test colistina, is confirmed if used in conjunction with the mueller hinton medium produced and developed by biomérieux, with a good concordance range when compared to the method of micro growth dilution (bmd), based on available data. 3 - there is a potential for false-sensitive results with the e-test colistin co 256 (ref. 537300 and 537308) when tested with mueller hinton media from other manufacturers, compared to the broth microdilution method (bmd). these data need to be confirmed, so the investigations are continuing and we are not mentioning what manufacturers are.
  • Action
    Field Action Code FCA 3206 triggered under the responsibility of bioMérieux. Company will send letter to customers.

Device

EthEST COLISTINE Technical Name: Etest COLISTINE Registration Number ANVISA: 10158120623 Hazard C...

Manufacturer

BIOMERIEUX S.A