BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASSYM

    MDR report key: 100287 · Received June 24, 1997

    Report

    Report Number
    MW1011558
    Event Type
    Malfunction
    Date Received
    June 24, 1997
    Date of Event
    May 21, 1997
    Report Date
    June 17, 1997
    Manufacturer
    ABBOTT DIAGNOSTICS
    Product Code
    LCI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NE, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAD A T4 PERFORMED ON THE AXSYM ON 5/20/97 IN THE EVENING AND A RESULT OF 3.7 WAS REPORTED. UPON FURTHER EVALUATION OF THIS TEST RESULT ON THE MORNING OF 5/21/97 IT WAS DECIDED TO REDRAW THE PT AND DOUBLE CHECK THIS T4 ON THE REDRAWN SPECIMEN. THE ORIGINAL SPECIMEN FROM 5/20/97 WAS ALSO RETESTED AND RESULTED IN A NORMAL RESULT COMPARABLE TO THE REDRAWN SPECIMEN. THIS DISCREPANCY IN THE T4 RESULTS WAS REPORTED AS POSSIBLY DUE TO AN INSTRUMENT ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASSYM IMMUNOASSAY INSTRUMENTATION LCI ABBOTT DIAGNOSTICS * 7563

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other