Events

Alerte De Sécurité sur Vancomycin

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

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
    2016-05-31
  • Date de publication de l'événement
    2016-05-31
  • 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_20160531b.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: roche diagnostics vancomycin medical device manufacturer, roche diagnostics, has issued a medical device safety alert concerning the following products: 04491050190 online tdm vancomycin 100 tests 05108420190 online tdm vancomycin 200 tests 04642490190 hitachi vancomycin (p) 04642481190 hitachi vancomycin (p) 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 medical risk of toxic effects due to the increased vancomycin dosage cannot be excluded. incorrect method comparison will be deleted from the ifus. affected users are instructed to ignore the wrong method comparison in the ifus. 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 31 may 2016.

Device

Vancomycin
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Roche Diagnostics Vancomycin
  • Manufacturer
    Roche Diagnostics

Manufacturer

Roche Diagnostics