BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMX ANALYZER

    MDR report key: 409401 · Received August 2, 2002

    Report

    Report Number
    1628664-2002-00039
    Event Type
    Other
    Date Received
    August 2, 2002
    Date of Event
    June 28, 2002
    Report Date
    August 1, 2002
    Manufacturer
    ABBOTT MANUFACTURING INC.
    Product Code
    LCI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A PT'S SERUM SAMPLE GENERATED AN IMX BHCG ASSAY RESULT OF 1374 MLU/ML. TWO DAYS PRIOR, THIS PT TESTED WITH A RESULTS OF 2808 MLU/ML. THE PT WAS TOLD THAT THEIR BHCG LEVELS WERE DROPPING AND THEY COULD POSSIBLY MISCARRY. FIVE DAYS LATER, ANOTHER SAMPLE WAS DRAWN WITH A RESULT OF 26028 MLU/ML. THE SAMPLE THAT GENERATED THE RESULT OF 1374MLU/ML WAS REPEATED AT THIS TIME WITH A RESULT OF 4978 MLU/ML. CONTROLS WERE WITHIN SPECIFICATIONS ON ALL RUNS. THE PT'S STATUS WAS MOVED TO PRE-NATAL. THERE IS NO IMPACT TO PT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMX ANALYZER AUTOMATED IMMUNOASSAY ANALYZER LCI ABBOTT MANUFACTURING INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR LN 1A06-22, IMX BHCG ASSAY, LOT 87358Q100.