BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS CMV LGG ASSAY

    MDR report key: 538239 · Received June 15, 2004

    Report

    Report Number
    3002769706-2004-00007
    Event Type
    Malfunction
    Date Received
    June 15, 2004
    Date of Event
    April 20, 2004
    Report Date
    June 14, 2004
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    LFZ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPOTS A DIFFERENCE BETWEEN TWO SEROLOGICAL TESTS PERFORMED IN A TWO (2) MONTH INTERVAL. IN MARCH, THE PT SAMPLE WAS TESTED WITH VIDAS CMV LGG ASSAY LOT 781649001 AND GAVE A NEGATIVE RESULT (<4AU/ML). A MONTH LATER, ANOTHER SAMPLE FROM THE SAME PT WAS TESTED WITH VIDAS CMV IGG ASSAY LOT 783391801 AND GAVE A POSITIVE RESULT (8AU/ML). THE MARCH SAMPLE WAS RETESTED ON LOT 783391801 AND GAVE A POSITIVE RESULT (8AU/ML). THE TWO SAMPLES WERE TESTED WITH A COMPETITOR ASSAY AND BOTH GAVE NEGATIVE RESULTS. THE SAMPLES WERE RE-TESTED AT THE BIOMERIEUX, INC. QUALITY CONTROL LABORATORY WITH THE FOLLOWING RESULTS: -NEGATIVE (<4 AU/ML) WITH VIDAS CMV LGG ASSAY LOT 782752601 -POSITIVE (6 AU/ML) WITH VIDAS CMV LGG ASSAY LOT 782752601 -POSITIVE (6 AU/ML) WITH VIDAS CMV LGG ASSAY LOT 783391801 -NEGATIVE ON A COMPETITOR REAGENT. IN SUMMARY, SAMPLES TESTING WITH VIDAS CMV IGG ASSAY LOT 783391801 GIVE POSITIVE RESULTS, WHILE NEGATIVE RESULTS ARE FOUND WITH OTHER VIDAS CMV IGG ASSAY LOTS AND COMPETITOR REAGENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIDAS CMV LGG ASSAY IMUNOASSAY, CYTOMEGALOVIRUS LFZ BIOMERIEUX, INC. NA 783391801

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN