BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMX ANALYZER

    MDR report key: 271647 · Received March 27, 2000

    Report

    Report Number
    1628664-2000-00016
    Event Type
    Other
    Date Received
    March 27, 2000
    Report Date
    March 24, 2000
    Manufacturer
    ABBOTT LABORATORIES, INC.
    Product Code
    JHI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE ACCOUNT REPORTED AN HUMAN CHORIONIC GONADOTROPIN RESULT OF 800 IU/L. THE PT WAS TAKEN TO SURGERY AND NOTHING WAS FOUND. FOLLOW-UP TESTING WAS RUN WHICH GAVE RESULT OF <1.0 IU/L. FURTHER INFO HAS BEEN REQUESTED REGARDING THIS INCIDENT BUT NO REC'D TO DATE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN