BEUDAMED
    FDA Adverse Event Other Summary report: N

    ANEUVYSION PRENATAL KIT

    MDR report key: 1240903 · Received November 12, 2008

    Report

    Report Number
    3005248192-2008-00004
    Event Type
    Other
    Date Received
    November 12, 2008
    Date of Event
    October 6, 2008
    Report Date
    November 4, 2008
    Manufacturer
    ABBOTT MOLECULAR
    Product Code
    MAO
    PMA / PMN Number
    K010288
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MONTHS AGO, CUSTOMER PERFORMED ANEUVYSION TEST (LOT NUMBER 406681) ON AMNIOTIC FLUID. THE ANEUVYSION RESULT FOR THE PT (NORMAL RESULT) WAS REPORTED OUTSIDE OF THE LAB. THE CHILD WAS BORN WITH DOWN SYNDROME, THE CUSTOMER RE-TESTED THE SAME AMNIOTIC FLUID (WHICH WAS STORED DURING THIS TIME), WITH OTHER ANEUVYSION LOT NUMBER AND THE RESULT WAS POSITIVE FOR THE TRISOMY 21. THE ANEUVYSION LOT IN QUESTION (LOT NUMBER 406681) WAS TESTED INTERNALLY AND HAS PERFORMED AS EXPECTED. THE INVESTIGATION CONTINUES. ABBOTT MOLECULAR IS IN CONTACT WITH THE USER FACILITY TO DETERMINE ROOT CAUSE OF THIS INCIDENT. NO ACTIONS HAVE BEEN TAKEN. THERE IS NO EVIDENCE OF MALFUNCTION. NO HARM TO PT (CHILD) WAS DONE. THIS INCIDENT IS BEING REPORTED DUE TO THE MENTAL ANGUISH ANTICIPATED ON PARENTS OF A CHILD WITH DOWN SYNDROME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEUVYSION PRENATAL KIT ANEUVYSION MAO ABBOTT MOLECULAR NA 406681

    Patients

    Seq Age Sex Outcome Treatment
    1