BEUDAMED
    FDA Adverse Event Other Summary report: N

    FACTOR II (G20210A) BIPLEX FORMAT

    MDR report key: 686156 · Received May 10, 2006

    Report

    Report Number
    2134294-2006-00001
    Event Type
    Other
    Date Received
    May 10, 2006
    Date of Event
    February 23, 2006
    Report Date
    March 13, 2006
    Manufacturer
    THIRD WAVE TECHNOLOGIES, INC.
    Product Code
    MVU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    PATIENT SAMPLE WAS TESTED AT MEDICAL CENTER 3 TIMES WITH THE INVADER ASR ON 1/24/06. THE INITIAL RESULT WAS A HETEROZYGOUS (HET) GENOTYPE CALL FOLLOWED BY TWO WILD TYPE (WT) CALLS IN SEPARATE RUNS. THE LAB DIRECTOR BELIEVED THE HET RESULT WAS DUE TO AN ABNORMALLY LARGE AMOUNT OF DNA USED BASED ON THE SIGNAL STRENGTH. IN OTHER WORDS, THE DISCREPANT RESULT WAS LIKELY DUE TO TECHNOLOGIST ERROR RATHER THAN INSTRUMENT OR ASSAY-SPECIFIC ERROR. THE CLINCIAN SUBMITTED AN ADDITIONAL BLOOD SAMPLE FROM THE PATIENT FOR TESTING THE NEW RESULT WAS A WT GENOTYPE CALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FACTOR II (G20210A) BIPLEX FORMAT ANALYTE SPECIFIC REAGENT MVU THIRD WAVE TECHNOLOGIES, INC. * 02121358

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other