Events

Field Safety Notices about ONLINE TDM Gentamicin assay

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by Roche Diagnostics.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Date
    2016-05-23
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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