BEUDAMED
    FDA Adverse Event Other Summary report: N

    VANCOMYCIN REAGENT

    MDR report key: 393072 · Received May 6, 2002

    Report

    Report Number
    MW1024926
    Event Type
    Other
    Date Received
    May 6, 2002
    Date of Event
    April 26, 2002
    Report Date
    May 3, 2002
    Manufacturer
    BAYER CORP.
    Product Code
    LEH
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REAGENTS FOR QUANTIFICATION OF VANCOMYCIN IN BLOOD USING IMMUNO-1 DID NOT PROVIDE ACCURATE VALUES FOR ONE PT ON MULTIPLE SPECIMENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VANCOMYCIN REAGENT IMMUNO-I ANALYZER LEH BAYER CORP. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other