Events

Avis De Sécurité sur ONLINE TDM Gentamicin assay

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 Diagnostics.

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
  • Date
    2016-05-23
  • 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
    Investigations have confirmed an increase in native patient sample result recovery of approximately 15-20 % when using online tdm gentamicin with recent preciset tdm i lots 615118, 619681, 126387, 140735. tdm controls and eqa (external quality assessment) samples also show an increased recovery of approximatively 15%. a combination with tdm control set lot 125783 does not show this effect. these observations were confirmed for the online tdm gentamicin reagent kits for use on cobas c and modular analytics

    comparing recovery with previous vs. recent preciset tdm i lots but also compared to gentamicin on cobas integra (gentm). the issue is most likely related to the preciset tdm i calibrator. based upon internal data the online tdm gentamicin reagent is showing an increased recovery. in .

Device

ONLINE TDM Gentamicin assay

Manufacturer

Roche Diagnostics