BEUDAMED
    FDA Adverse Event Other Summary report: N

    HYBRITECH ICON II HCG

    MDR report key: 149714 · Received February 13, 1998

    Report

    Report Number
    2022635-1998-00001
    Event Type
    Other
    Date Received
    February 13, 1998
    Date of Event
    December 19, 1997
    Report Date
    February 11, 1998
    Manufacturer
    BECKMAN INSTRUMENTS, INC.
    Product Code
    JHI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A PT PRESENTED AT THE USER FACILITY ON 12/19/1997 WITH ABDOMINAL PAINS. AN ICON HCG TEST FOR PREGNANCY WAS PERFORMED ON THE PTS SERUM WITH NEGATIVE RESULTS. ALL CONTROLS PERFORMED AS EXPECTED. THE PT WAS THEN GIVEN X-RAYS OF THE CHEST, KIDNEYS, URETER AND BLADDER. THE X-RAYS DID NOT IDENTIFY A CAUSE OF THE ABDOMINAL PAIN. ON 1/3/98 THE PT WAS GIVEN AN ULTRASOUND AND A FETUS OF APPROX 5 WEEKS WAS IDENTIFIED. NO PT SAMPLE WAS AVAILABLE FOR FURTHER TESTING. PT INDICATED THAT HER LAST MENSES WAS 11/28/97. THE ICON HCG KIT INSTRUCTIONS INDICATE THAT THE SENSITIVITY FOR SERUM SAMPLE IS 10MLU/ML AND IN MOST CASES ELEVATED HCG WILL BE DETECTED IN THE FIRST WEEK AFTER IMPLANTATION OR 4-5 DAYS BEFORE A MISSED MENSES. ESTIMATED MISSED MENSES FOR THIS PT WOULD BE APPROX 12/27/97. BASED ON CURRENTLY AVAILABLE INFO, IT APPEARS THAT THE HCG LEVELS MAY HAVE BEEN BELOW 10 MLU/ML ON 12/19/97. IF THIS IS THE CASE, THEN ICON HCG TEST KIT PERFORMED ACCORDING TO LABELED CLAIMS. LABELING ALSO STATES THAT WHEN A NEGATIVE RESULT IS OBTAINED AND PREGNANCY IS SUSPECTED, A SECOND ICNO HCG TEST SHOULD BE PERFORMED ON A NEW SAMPLE 48 HOURS OR MORE AFTER THE INITIAL TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYBRITECH ICON II HCG HCG IMMUNOCONCENTRATION TEST KIT JHI BECKMAN INSTRUMENTS, INC. ICON II HCG 790186

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other