BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALT (SGPT) TEST SLIDE CARTRIDGE PACK

    MDR report key: 17563 · Received November 10, 1994

    Report

    Report Number
    MW1003979
    Event Type
    Malfunction
    Date Received
    November 10, 1994
    Date of Event
    October 4, 1994
    Report Date
    October 24, 1994
    Manufacturer
    EASTMAN KODAK CO.
    Product Code
    CJJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NE, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ORIGINAL (INCORRECT) ALT RESULT WAS SENT TO FLOOR ON A PT. AFTER SEVERAL PTS WERE ASSAYED WITH THE SAME LOW RESULTS, CONTROLS WERE RUN ON ALT AND ALSO FOUND TO BE LOW. ALT CARTRIDGE WAS REPLACED WITH ANOTHER ONE OF THE SAME LOT #. CONTROLS WERE RUN AND WERE SATISFACTORY. PT ALT WAS RERUN ON SLIDES FROM NEW CARTRIDGE AND CORRECT RESULT WAS TRANSMITTED TO THE FLOOR. NO EXPLANATION OR DETERMINATION MADE OF WHY THE ONE ALT CARTRIDGE PRODUCED ERRONEOUS ALT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALT (SGPT) TEST SLIDE CARTRIDGE PACK TEST SLIDE CARTRIDGE CJJ EASTMAN KODAK CO. 7957

    Patients

    Seq Age Sex Outcome Treatment
    1 * KODAK EKTACHEM CHEMISTRY ANALYZER