BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICON II HCG (SERUM)

    MDR report key: 54945 · Received December 4, 1996

    Report

    Report Number
    2022635-1996-00010
    Event Type
    Malfunction
    Date Received
    December 4, 1996
    Report Date
    December 4, 1996
    Manufacturer
    HYBRITECH, INC.
    Product Code
    JHJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A FEMALE PT UNDERGOING FERILITY TREATMENT HAD A SERUM SAMPLE TESTED ON THE HCG SERUM ASSAY. THE RESULT OF NEGATIVE. THE SAMPLE WAS QUANTITATED (METHOD UNKNOWN) AND THE RESULT WAS 50MLU/ML HCG. ANOTHER SAMPLE WAS DRAWN AND TESTED ON THE ASSAY WITH A NEGATIVE RESULT. THE SAMPLE WAS QUANTITATED AND THE RESULT WAS 100 MLU/ML HCG. A 3RD DRAW FROM THE PT RESULTED IN A POSITIVE CO'S RESULT. THE 3RD SAMPLE QUANTITATED AT 800 MLU/ML HCG. THE 2ND AND 3RD SAMPLES AND PART OF THE KIT WERE RETURNED TO CO FOR IN-HOUSE EVAL. THREE CYLINDERS WERE RETURNED FROM THE CUSTOMER. SAMPLE 2 AND A NEGATIVE AND POSITIVE CONTROL WERE RUN USING THOSE CYLINDERS. BOTH SAMPLES WERE TESTED USING AN IN-HOUSE KIT OF THE SAME LOT NUMBER. BOTH SAMPLES WERE QUANTITATED USING ANOTHER ASSAY NEAT AND AFTER BEING SPIKED WITH A HETEROPHILE BLOCKING REAGENT (HBR). THE RESULTS OF THE EVAL ARE NOTED IN SECTION 1110.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICON II HCG (SERUM) HCG TEST JHJ HYBRITECH, INC. NA 690645

    Patients

    Seq Age Sex Outcome Treatment
    1 *