Events

Avis De Sécurité sur ONLINE TDM Vancomycin

Selon Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Slovenia qui a été fabriqué par Roche.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Field Safety Notice
  • Pays de l'événement
    Slovenia
  • Source de l'événement
    AMPMDRS
  • Notes / Alertes
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 recall data from the U.S. and Slovenia.
  • Notes supplémentaires dans les données
  • Cause
    The ifus (instructions for use) for vancomycin on cobas c 311/501/502 and modular analytics p-module state an incorrect method comparison against cobas integra® 800. since the cobas integra reagent is not yet adapted, results generated with cobas integra are still up to 20 % higher than with cobas c or modular analytics p-module. the method comparison shown may lead to the assumption that both methods are comparable and may affect the interpretation of vancomycin test results. the issue can potentially lead to misinterpretation of results. in case that the first result has been generated with integra and the following result using cobas/hitachi assay, the difference between assays might be interpreted as decrease in vancomycin concentration which can further trigger the increase in the dosage. in this case, a .

Device

ONLINE TDM Vancomycin
  • Modèle / numéro de série
    ONLINE TDM Vancomycin 100 tests ONLINE TDM Vancomycin 200 tests HITACHI VANCOMYCIN (911, 912, 917, P) HITACHI VANCOMYCIN (917, P)
  • Manufacturer
    Roche

Manufacturer

Roche