BEUDAMED
    FDA Adverse Event Other Summary report: N

    ICON 25 HCG

    MDR report key: 499955 · Received November 20, 2003

    Report

    Report Number
    2916283-2003-00031
    Event Type
    Other
    Date Received
    November 20, 2003
    Date of Event
    October 16, 2003
    Report Date
    November 20, 2003
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JHI
    Removal / Correction Number
    NOT APPLICABLE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER CALLED BECKMAN COULTER REGARDING THREE DISCREPANT URINE TEST RESULTS FROM THREE DIFFERENT PTS. WHEN THE PTS WERE TESTED ALL THREE PTS TESTED NEGATIVE (-) WITH THE ICON 25 HCH TEST KIT. THE PT'S SAMPLE WERE RETESTED FOR HCG USING AN UNK METHOD. ALL THREE PT SAMPLES GENERATED POSITIVE RESULTS. THERE HAS BEEN NO CHANGE TO PT TREATMENT THAT CAN BE ATTRIBUTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICON 25 HCG QUALITATIVE HCG TEST JHI BECKMAN COULTER INC. NA HCG030303

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other