BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIRONOSTIKA HTLV I/II

    MDR report key: 398280 · Received May 17, 2002

    Report

    Report Number
    MW4003252
    Event Type
    Malfunction
    Date Received
    May 17, 2002
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    MTP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ASSAYS APPROVED BY THE CENTER FOR BIOLOGICS AND RESEARCH (CBER) FOR USE IN BLOOD DONOR SCREENING MUST INDICATE THE SPECIFICITY OF THE PRODUCT IN THE PACKAGE INSERT. THE PACKAGE INSERT FOR THE VIRONOSTIKA HTLV I/II ASSAY (MFG BY BIOMENEUX, INC., HAZELWOOD, MO AND DISTRIBUTED BY ORTHO CLINICAL DIAGNOSTIC, RARITAN, NJ) STATES THAT THE ASSAY HAS A CALCULATED SPECIFICITY OF 99.95%. THE LABORATORIES HAVE USED THE ABOVE ASSAY SINCE MID- 1997. THIS COMPLAINT FOCUSES ON THE DONOR SCREEING EXPERIENCE THROUGH 2001. DURING THIS PERIOD, BOTH THE INITIAL AND REPEAT REACTIVE RATES HAVE CONSISTENTLY EXCEEDED THE ESTIMATED SPECIFICITY BASED ON CLINICAL DATA PUBLISHED IN THE PACKAGE INSERT. THIS LACK OF SPECIFICITY HAS RESULTED IN THE LOSS OF THOUSANDS OF DONORS FROM THE VOLUNTEER BLOOD DONOR POOL. THE LABORATORIES PERFORM IN EXCESS OF 7 MILLION DONOR SCREENING PROFILES ANNUALLY AND ARE GEOGRAPHICALLY LOCATED THROUGHOUT THE COUNTRY. THE SPECIFICITY OF THIS ASSAY EXPERIENCED ACROSS THE SYSTEM IN 2001 WAS 99.92% WITH A 95% CI OF 99.91-99.92% BASED ON 7.338 MILLITON TESTS ON DONOR SAMPLES. THE SPECIFICITY STATED IN THE PACKAGE INSERT IS 99.95% WITH A 95% CI OF 99.89-99.98% BASED ON 11,415 TESTS ON DONOR SAMPLES. MULTIPLE COMPLAINTS HAVE BEEN FILED WITH THE DISTRIBUTOR (ORTHO CLINICAL DIAGNOSTICS) REGARDING THE POOR PERFORMANCE CHARACTERISTICS OF THIS ASSAY. SEVERAL MONTHS FOLLOWING THE INITIAL COMPLAINTS THE REPORTER WAS NOTIFIED THAT THE VENDOR (BIOMERIEUX, INC.) COULD NOT DUPLICATE THE RESULTS EXPERIENCED. THE VENDOR HAS STATED THAT THEY HAVE NOT OBSERVED A TREND OR DRIFT OF SPECIFICITY WHEN THE ASSAY IS TESTED WITH IN-HOUSE PANELS AND ARE UNABLE TO DEMONSTRATE ANY DEVIATION IN PRODUCT PERFORMANCE THAT CORRESPONDS TO THE FIELD REACTIVE RATE EXPERIENCE. THE DATA FROM THE REPORTERS EXPERIENCE WITH THE VIRONOSTIKA HTLV I/II ASSAY INDICATE THAT THE CLINICAL DATA REPRESENTED IN THE PACKAGE INSERT REPRESENT AN INADEQUATE SAMPLE SIZE TO DETERMINE TRUE ASSAY SPECIFICITY. THEY WOULD RECOMMEND THAT THE PACKAGE INSERT BE MODIFIED TO REFLECT THE TRUE PERFORMANCE OF THE ASSAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIRONOSTIKA HTLV I/II BLOOD DONOR SCREENING ASSAY MTP BIOMERIEUX, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *