BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMX ANALYZER

    MDR report key: 288776 · Received August 4, 2000

    Report

    Report Number
    1628664-2000-00052
    Event Type
    Other
    Date Received
    August 4, 2000
    Date of Event
    June 26, 2000
    Report Date
    August 3, 2000
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    LCI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON JUNE 26, 2000 A CUSTOMER REPORTED A IMX BHCG VALUE OF 38,00MIU/ML. THE PHYSICIAN QUESTIONED THE RESULT, EXPECTING A HIGHER RESULT. THE SAME SAMPLE WAS REPEATED TWICE ON THE IMX AND ONCE ON A COMPETITOR'S METHODOLOGY. ALL THREE RESULTS APPROXIMATED 163,000 MIU/ML, WHICH WAS REPORTED TO THE PHYSICIAN. THERE IS NO REPORT OF IMPACT TO PT MANAGEMENT.

    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 29 YR IMX BHCG ASSAY, LIST NUMBER 1A06-22,| LOT NUMBER 63129Q100, EXP. 11/8/00.