BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHEMSTRIP SUPER UA

    MDR report key: 382285 · Received March 12, 2002

    Report

    Report Number
    1823260-2002-00073
    Event Type
    Malfunction
    Date Received
    March 12, 2002
    Date of Event
    February 15, 2002
    Report Date
    March 1, 2002
    Manufacturer
    HITACHI HIGH TECH. CORP.
    Product Code
    KQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    URINE COLLECTED AND RUN ON SUSPECT DEVICE. EMERGENCY ROOM QUESTIONED RESULTS. AT SAME TIME, TESTED URINE MANUALLY AND ALL RESULTS WERE POSITIVE. WHEN URINE RAN ON SUSPECT DEVICE, BLOOD, NITRITES, LEUKOCYES AND PROTEIN REPORTED OUT ALL NEGATIVE. LAB REPEATED TESTING AND ALL RESULTS WERE POSITIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHEMSTRIP SUPER UA URINALAYSIS ANALYZER KQO HITACHI HIGH TECH. CORP. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR