BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMX ANALYZER

    MDR report key: 284440 · Received June 26, 2000

    Report

    Report Number
    1628664-2000-00039
    Event Type
    Other
    Date Received
    June 26, 2000
    Date of Event
    May 19, 2000
    Report Date
    June 21, 2000
    Manufacturer
    ABBOTT LABORATORIES, INC.
    Product Code
    LCI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED IMX BETA-HUMAN CHORIONIC GONADOTROPIN VALUE OF 3158 MIU/ML. VALUE WAS QUESTIONED BY PHYSICIAN. PT WAS REDRAWN AND SAMPLE YIELDED A VALUE OF 21,000 MIU/ML. THE ORIGINAL SAMPLE WAS RETESTED AND YIELDED A VALUE OF 12,884 MIU/ML, CONSISTENT WITH OTHER LAB RESULTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR IMX TOTAL BHCG ASSAY, LIST NUMBER 1A06.