BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CMV IGM CAPTURE

    MDR report key: 714338 · Received April 12, 2006

    Report

    Report Number
    714338
    Event Type
    Malfunction
    Date Received
    April 12, 2006
    Date of Event
    March 20, 2006
    Report Date
    April 12, 2006
    Manufacturer
    DIAMEDIX CORPORATION
    Product Code
    GQH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DIAMEDIX CHANGED THE ANTIGEN (CMV) USED IN THE TEST KITS PURCHASED BY THE HOSPITAL LABORATORY FOR PERFORMING CMVIGM TESTING. A NOTE WAS PROVIDED IN THE KIT TO ANNOUNCE THE PRODUCT CHANGE AND TO SAY THAT PERFORMANCE SHOULD NOT BE AFFECTED. PRIOR TO THIS CHANGE, THE LABORATORY EXPERIENCED 1 POSITIVE CMVIGM PER EVERY 3 TEST RUNS AND 1 EQUIVOCAL PER EVERY 5 TEST RUNS. AFTER THE CHANGE, THE LAB BEGAN TO SEE A HIGHER INCIDENCE OF POSITIVE RESULTS (1 PER RUN) AND EQUIVOCAL RESULTS (2 PER RUN). TECH SERVICES AT DIAMEDIX HAS BEEN CONTACTED AND THE RAW DATA HAS BEEN FAXED TO THEM. A PARTIALLY USED TEST KIT WAS ALSO RETURNED ALONG WITH SOME BLIND SAMPLES FOR THEM TO USE WITH THE PARTIALLY USED KIT. ALL SAMPLES WITH POSITIVE AND EQUIVOCAL TEST RESULTS ARE BEING SENT TO AN OFF SITE REFERENCE LAB FOR CONFIRMATION UNTIL THIS SITUATION IS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CMV IGM CAPTURE TEST KIT, ANTIGEN GQH DIAMEDIX CORPORATION * 90505Z

    Patients

    Seq Age Sex Outcome Treatment
    1 *