Events

Alerte De Sécurité sur VITEK 2 Gram-Negative AST cards

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par BioMérieux.

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
  • Date
    2017-05-19
  • Date de publication de l'événement
    2017-05-19
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170520b.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: biomérieux vitek 2 gram-negative ast cards medical device manufacturer, biomérieux, has issued a medical device safety alert concerning its vitek 2 gram-negative ast cards. the manufacturer has identified a performance issue with colistin (cs01n). eucast and clsi recently issued a joint recommendation that broth-microdilution (bmd) is the only validated method for antimicrobial susceptibility testing (ast) of colistin. as the vitek 2 ast-gn colistin (cs01n) was developed to agar dilution (ad), an internal biomérieux investigation was conducted to identify any shift in performance for colistin (cs01n) since the vitek 2 colistin (cs01n) test was developed. investigational testing included vitek 2, broth-microdilution and agar dilution using 290 isolates with varying degrees of susceptibility and resistance to colistin. two qc organisms (e.Coli atcc 25922 and p. aeruginosa atcc 27853) were also included in the testing. minimal inhibitory concentration (mic) results from the three methods were compared and evaluated. according to the manufacturer, the investigation demonstrated a high rate of very major errors (resistant isolates calling susceptible) with the vitek 2 ast-gn colistin (cs01n) compared to agar dilution (the reference method used for cs01n development) and compared to broth-microdilution (recommended method by eucast/clsi). since the development of vitek 2 ast-gn colistin (cs01n), higher resistance rates have been reported. in november 2015 plasmid mediated transferable colistin resistance (mcr-1 gene) was reported and heterogeneous resistance is reported more frequently. evaluation of the identified issue indicates the potential for false susceptible colistin results. a false susceptible result could have a negative influence on the treatment decision as the drug may be chosen for therapy. inappropriate treatment could be prescribed resulting in treatment failure. the manufacturer advises users to perform an alternate method of testing prior to reporting colistin (cs01n) results. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 19 may 2017.

Device

VITEK 2 Gram-Negative AST cards
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: BioMérieux VITEK 2 Gram-Negative AST cards
  • Manufacturer
    BioMérieux

Manufacturer

BioMérieux