BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QIAGEN HVC RNA PCR TESTING KITS

    MDR report key: 686363 · Received February 21, 2006

    Report

    Report Number
    MW1038089
    Event Type
    Malfunction
    Date Received
    February 21, 2006
    Date of Event
    December 13, 2005
    Report Date
    February 21, 2006
    Manufacturer
    *
    Product Code
    MZO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RPTR GOT A COPY OF A LETTER FROM THEIR DR WHO TREATED RTPR FOR HEPATITIS C, AND THEY HAD TO HAVE BLOOD TESTS UP TO ONCE A WEEK AT THE LAB. THE DIAGNOSIS WAS IN 2003, TREATMENT STARTED FOUR MOS LATER AND ENDED THREE MOS LATER. RPTR HAD TO CONTINUE HAVING BLOOD TESTS DONE THROUGHOUT THIS TIME, AND FOR OVER A YEAR BEYOND THAT TIME. RPTR WENT TO ONE LAB FOR ALL THE LAB WORK. IN THE LETTER THE LAB SENT IS THE FOLLOWING: "I'M WRITING TO INFORM YOU ABOUT AN ISSUE RELATING TO HEPATITIS C VIRUS -HVC-RNA PCR RESULTS THAT WERE REPORTED FOR YOUR PTS. 'OUR MFR OF THE RNA PURIFICATION KIT USED FOR HVC RNA PCR TESTING HAS NOTIFIED THAT THERE MAY HAVE BEEN "REDUCED SENSITIVITY" WITH SOME LOTS OF THEIR PROUDCT. THE REDUCED SENSITIVITY COULD HAVE CAUSED UP TO A HALF LOG -APPROX. FOUR FLOD- UNDER-REPORTING OF RESULTS. THE AFFECTED PRODUCT LOTS WERE USED FOR TESTING FROM 03/01/2004 TO 04/16/2005. 'WE HAVE COMPLETED A SEARCH OF OUR LABORATORY INFO SYSTEM TO IDENTIFY THE PTS WHO MEET THE FOLLOWING CRITERIA: 1- THE LAST HVC RNA PCR RESULT REPORTED DURING THE AFFECTED TIME PERIOD WAS "NOT DETECTED" -<50 IU/ML OR <1.70 LOG IU/ML- AND 2- CO HAS NO RECORD OF HAVING PERFORMED HCV RNA PCR TESTING AFTER AFFECTED TIME PERIOD. 'ABOVE, PLEASE FIND INFO ABOUT YOUR AFFECTED PT, INCLUDING THE SPECIFICS OF THE LAST HCV RNA PCR RESULTS REPORTED AS "NOT DETECTED."...

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QIAGEN HVC RNA PCR TESTING KITS * MZO * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other