Events

Alerte De Sécurité sur ETEST XM256 (Cefuroxime) FOAM and SPB

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

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
    2017-01-25
  • Date de publication de l'événement
    2017-01-25
  • 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_20170125.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: biomerieux etest xm256 (cefuroxime) foam and spb medical device manufacturer, biomerieux, has issued field safety notices (fsn) concerning its etest xm256 (cefuroxime) foam and spb (foam reference numbers: 506958, 506918 and spb reference numbers: 412304, 412305) an analysis was performed on the essential agreement rate reflecting the minimum inhibitory concentrations (mic) result obtained by the product for a significant strains kit including enterobacteriaceae, haemophilus and s. pneumonia species. then, an additional analysis was done on the clinical categorization of the strains based on clsi guidance. according to the manufacturer, the following have been identified: the investigation confirmed a potential performance issue on strains categorization for streptococcus pneumoniae and for enterobacteriaceae strains limited to oral cefuroxim breakpoints and based on 2016 clsi clinical standards only: for streptococcus pneumoniae on etestr xm256 (cefuroxime) foam and spb that could lead to minor error on clinical strains false susceptible result instead of intermediate results with bmd (broth micro dilution) reference method false intermediate result instead of resistant results with bmd reference method for enterobacteriaceae on etestr xm256 (cefuroxime) foam and spb that could lead to minor error on clinical strains: false susceptible result instead of intermediate results with ad (agar dilution) reference method false intermediate result instead of resistant results with ad reference method. products perform within the specification when using the 2016 eucast guidelines. as the result of the referenced issue, the potential hazard is to obtain minor error (susceptible instead of intermediate or intermediate instead of resistant) on strain categorization for streptococcus pneumoniae and for enterobacteriaceae strains only when using the 2016 clsi clinical breakpoints defined for cefuroxime oral forms. the affected users are advised to follow the instructions and implement the actions as indicated in the fsn. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 25 january 2017.

Device

ETEST XM256 (Cefuroxime) FOAM and SPB
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: BioMerieux ETEST XM256 (Cefuroxime) FOAM and SPB
  • Manufacturer
    BioMerieux

Manufacturer

BioMerieux