BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMX ANALYZER

    MDR report key: 288613 · Received July 31, 2000

    Report

    Report Number
    1628664-2000-00049
    Event Type
    Other
    Date Received
    July 31, 2000
    Date of Event
    June 23, 2000
    Report Date
    July 28, 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

    CUSTOMER REPORTED OUT IMX BETA-HUMAN CHORIONIC GONADOTROPHIN RESULTS OF 1956 MIU/ML FOR ONE SAMPLE AND 13,630 MIU/ML FOR ANOTHER SAMPLE DRAWN A FEW DAYS LATER FROM THE SAME PT. A PHYSICIAN QUESTIONED THE RESULTS. THE PT RECEIVED AN ADDITIONAL ULTRASOUND AND BLOOD TESTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR IMX BETA-HUMAN CHORIONIC GONADOTROPHIN ASSAY, LIST| NUMBER 1A06-22, LOT NUMBER 64865Q100.