BEUDAMED
    FDA Adverse Event Death Summary report: N

    ANEYVYSION MULTICOLOR DNA PROBE KIT

    MDR report key: 2371755 · Received May 12, 2011

    Report

    Report Number
    3005248192-2011-00005
    Event Type
    Death
    Date Received
    May 12, 2011
    Date of Event
    May 6, 2011
    Report Date
    May 12, 2011
    Manufacturer
    ABBOTT MOLECULAR, INC.
    Product Code
    MAO
    PMA / PMN Number
    K010288
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ABBOTT MOLECULAR HAS CONTACTED THE CUSTOMER AND REQUESTED MORE INFO REGARDING THIS EVENT. A F/U REPORT WILL BE SUBMITTED TO THE FDA AFTER MORE INFO IS RECEIVED FROM THE CUSTOMER.

    Description of Event or Problem · 1

    PRODUCT NAME: ANEUVYSION MULTICOLOR DNA PROBE KIT. INTENDED USE: THE ANEUVYSION (VYSIS CEP 18, X, Y-ALPHA SATELLITE, LS1 13 AND 21) MULTICOLOR PROBE PANEL IS INTENDED TO USE CEP 18/X/Y PROBE TO DETECT ALPHA SATELLITE SEQUENCES IN THE CENTROMERE REGIONS OF CHROMOSOMES 18, X, AND Y, AND LS1 13/21 PROBE TO DETECT THE 13Q 14 REGION AND THE 21Q22, 13 TO 21Q22.2 REGION. THE ANEUVYSION KIT IS INDICATED FOR IDENTIFYING AND ENUMERATING CHROMOSOMES 13, 18, 21, X, AND Y VIA FLUORESCENCE IN SITU HYBRIDIZATION (FISH) IN METAPHASE CELLS AND INTERPHASE NUCLEI OBTAINED FROM AMNIOTIC FLUID IN SUBJECTS WITH PRESUMED HIGH RISK PREGNANCIES. IT IS NOT INTENDED TO USED AS A STAND ALONE ASSAY FOR MAKING CLINICAL DECISIONS. FISH RESULTS ARE INTENDED TO BE USED AS AN AID IN THE DIAGNOSIS OF NUMERICAL ABNORMALITIES OF CHROMOSOMES 13, 18, 21, X AND/OR Y IN CONJUNCTION WITH OTHER INFO CURRENTLY USED IN PRENATAL DIAGNOSIS, CONSISTENT WITH PROFESSIONAL STANDARDS OF PRACTICE. THIS DEVICE IS INTENDED FOR USE ONLY WITH AMNIOCYTE CELLS; IT IS NOT INTENDED FOR AND HAS NOT BEEN VALIDATED FOR USE WITH OTHER TEST MATRICES. THIS FISH ASSAY WILL NOT DETECT THE PRESENCE OF STRUCTURAL CHROMOSOME ABNORMALITIES THAT CAN ALSO RESULT IN BIRTH DEFECTS. THIS FISH ASSAY WILL BE PERFORMED IN CYTOGENETICS LABORATORIES. A CUSTOMER IN GERMANY STATED THAT FALSE POSITIVE RESULTS WERE REPORTED WITH THE ANEUVYSION MULTICOLOR DNA PROBE KIT. THREE CEP16 SIGNALS WERE DETECTED AND REPORTED AS TRISOMY 16, BUT AFTER ABORTION FETUS WAS HEALTHY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEYVYSION MULTICOLOR DNA PROBE KIT DNA-PROBE, HUMAN CHROMOSOME, PRODUCT CODE: MAO MAO ABBOTT MOLECULAR, INC. 425879

    Patients

    Seq Age Sex Outcome Treatment
    1 1 HR Death