BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICON II HCG (URINE)

    MDR report key: 48698 · Received November 1, 1996

    Report

    Report Number
    2022635-1996-00007
    Event Type
    Malfunction
    Date Received
    November 1, 1996
    Date of Event
    September 18, 1996
    Report Date
    November 1, 1996
    Manufacturer
    HYBRITECH, INC.
    Product Code
    JHJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A PT WHO WAS 3 DAYS LATE FOR HER PERIOD HAD HER URINE TESTED USING THE HGC URINE ASSAY. THE RESULT WAS NEGATIVE. THE PT WAS TO HAVE A ENDOMETRIAL BIOPSY PERFORMED. THE LAB SUPV DECIDED TO DRAW A BLOOD SAMPLE FOR QUANTITIVE HCG TESTING (METHOD UNKNOWN). THE RESULT OF THE QUANTITATIVE TEST WAS 34MLU/ML. AN ULTRASOUND WAS THEN PERFORMED AND CONFIRMED THAT THE PT WAS PREGNANT. THE INITIAL URINE SAMPLE TESTED ON THE ASSAY WAS A FIRST MORNING VOID. AN OPENED KIT LOT/NUMBER 690604 WAS RETURNED FROM THE CUSTOMER FOR IN-HOUSE TESITNG. NO SAMPLE WAS RETURNED. NEGATIVE CONTROL, POSITIVE CONTROL AND POSITIVE CONTROL DILUTIONS WERE TESTED USING BOTH THE RETURNED KIT AND AN IN-HOUSE KIT OF THE SAME L/N. TESTING RESULTS WERE ACCEPTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICON II HCG (URINE) HCG TEST JHJ HYBRITECH, INC. NA 690604

    Patients

    Seq Age Sex Outcome Treatment
    1 *