BEUDAMED
    FDA Adverse Event Summary report: N

    MULTISTIX

    MDR report key: 15076 · Received July 29, 1994

    Report

    Report Number
    MW4000462
    Date Received
    July 29, 1994
    Date of Event
    May 10, 1994
    Report Date
    May 10, 1994
    Manufacturer
    AMES DIAGNOSTICS DIV. MILES LABS, INC.
    Product Code
    JJW
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    URINALYSIS SHOWED WBC TOO NUMEROUS TO COUNT BUT THIS DEVICE SHOWED "NEGATIVE," THEN ON REPEAT, "TRACE" WBC AT 2 MINUTES (WHEN SUPPOSED TO BE READ).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTISTIX JJW AMES DIAGNOSTICS DIV. MILES LABS, INC. A767023

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR