BEUDAMED
    FDA Adverse Event Other Summary report: N

    INVADER DNA ASSAY CONTROLS; FACTOR II (G20210A)

    MDR report key: 686221 · Received May 10, 2006

    Report

    Report Number
    2134294-2006-00003
    Event Type
    Other
    Date Received
    May 10, 2006
    Date of Event
    February 23, 2006
    Report Date
    May 10, 2006
    Manufacturer
    THIRD WAVE TECHNOLOGIES, INC.
    Product Code
    MVU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PATIENT SAMPLE WAS TESTED AT MEDICAL CENTER 3 TIMES WITH THE INVADER ASR IN 1/06. THE INITIAL RESULT WAS A HETEROZYGOUS (HET) GENOTYPE CALL FOLLOWEDBY TWO WILD TYPE (WT) CALLS IN SEPARATED RUNS. THE LAB DIRECTOR, INDICATED THAT THE INITIAL RESULTS PROMPTED THE CLINICIAN TO SUBJECT THE PATIENT TO ADDITIONAL SAMPLE COLLECTION. THE DIRECTOR FURTHER INDICATED THE THERAPEUTIC MANAGEMENT OF THIS PATIENT WAS NOT ADVERSELY AFFECTED BY THE INITIAL FALSE POSITIVE REPORT TO THE CLINICIAN. THE SECOND SAMPLE FROM THIS PATIENT WAS TESTED BY THE SAME LABORATORY WITH NO DISCREPANT RESULTS. THE CLINICIAN WAS PROMPTLY NOTIFIED OF THE SECONDARY RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INVADER DNA ASSAY CONTROLS; FACTOR II (G20210A) ANALYTE SPECIFIC REAGENT MVU THIRD WAVE TECHNOLOGIES, INC. * 02121365

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other