BEUDAMED
    FDA Adverse Event Other Summary report: N

    THIRD WAVE CFTR INPLEX AMPLIFICATION REAGENTS

    MDR report key: 689739 · Received May 10, 2006

    Report

    Report Number
    2134294-2006-00006
    Event Type
    Other
    Date Received
    May 10, 2006
    Date of Event
    February 15, 2006
    Report Date
    March 20, 2006
    Manufacturer
    THIRD WAVE TECHNOLOGIES, INC.
    Product Code
    NUA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE LAB INDICATED THAT 2 FALSE POSITIVE RESULTS (A HET CALL FOR THE R347P AND 3849-10KB ASSAYS) WERE REPORTED TO THE ORDERING PHYSICIANS. UPON RETESTING OF DNA FROM THE ORIGINAL SAMPLES, THE RESULTS REPORTED ON 2/15/06 WERE DISCOVERED TO HAVE BEEN FALSE-POSITIVE AND THE PHYSICIANS WERE NOTIFIED BY THE LAB USING AMENDED REPORTS AND BY TELEPHONE. THE FALSE POSITIVE RESULTS WERE USED FOR PT COUNSELING WHICH LED TO THE PHYSICIAN ORDERING A CF CARRIER SCREENING TEST ON A PT'S SPOUSE. THE LAB RECEIVED THE BLOOD SPECIMEN BUT TESTING WAS CANCELLED BEFORE RESULTS WERE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THIRD WAVE CFTR INPLEX AMPLIFICATION REAGENTS CFTR INPLEX AMPLIFICATION REAGENTS NUA THIRD WAVE TECHNOLOGIES, INC. * 02160782

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other