Events

Field Safety Notices about ONLINE TDM Vancomycin

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.

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
  • 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
    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
  • Model / Serial
    ONLINE TDM Vancomycin 100 tests ONLINE TDM Vancomycin 200 tests HITACHI VANCOMYCIN (911, 912, 917, P) HITACHI VANCOMYCIN (917, P)
  • Manufacturer
    Roche

Manufacturer

Roche