BEUDAMED
    FDA Adverse Event Other Summary report: N

    GS HIV-1/HIV-2 PLUS O EIA

    MDR report key: 1246385 · Received November 26, 2008

    Report

    Report Number
    3022521-2008-00007
    Event Type
    Other
    Date Received
    November 26, 2008
    Date of Event
    October 31, 2008
    Report Date
    November 25, 2008
    Manufacturer
    BIO-RAD LABORATORIES
    Product Code
    MZF
    PMA / PMN Number
    BL125030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ON (B)(6) 2008, BIO-RAD LABORATORIES TECHNICAL SUPPORT DEPARTMENT RECEIVED A CALL FROM (B)(6) IN (B)(6) REGARDING 2 SAMPLES FOR WHICH THEY OBTAINED DISCREPANT RESULTS IN COMPARISON TO RESULTS OBTAINED AT ANOTHER TESTING SITE. TESTING AT BOTH SITES WAS PERFORMED WITH THE (B)(4) ASSAY, USING DIFFERENT KIT LOTS. THE ORIGINAL TESTING AT THE FIRST SITE (WITH KIT LOT 176BB) WAS POSITIVE FOR EACH SAMPLE, WITH SIGNAL CUT-OFF (S/CO) RESULTS FOR THE FIRST SAMPLE OF 2.556 AND 3.108 AND S/CO RESULTS FOR THE SECOND SAMPLE OF 2.147. AT (B)(6), RESULTS FOR BOTH SAMPLES (WITH KIT LOT 191CBB) WERE NON-REACTIVE (S/CO OF 0.794 AND 0.733 FOR SAMPLE #1 AND 0.598 AND 0.471 FOR SAMPLE #2). (B)(6) TESTING WAS THEN PERFORMED USING THE BIO-RAD (B)(4) ASSAY, AND BOTH SAMPLES WERE POSITIVE. ADDITIONAL TESTING ON LOT NUMBER 225CBB OF THE (B)(4) WAS ALSO PERFORMED AT THE SITE, AND RESULTS WERE REACTIVE JUST ABOVE THE CUTOFF FOR SAMPLE #1 AND HIGH NEGATIVE FOR SAMPLE #2. PCR TESTING ON SAMPLE #2 WAS PERFORMED PRIOR TO TESTING AT (B)(6), WITH A VIRAL LOAD OF 920,329 COPIES/ML. ADDITIONAL TESTING HAS BEEN PERFORMED AT BIO-RAD ON BOTH SAMPLES, WITH THE (B)(4) (ONE SAMPLE REACTIVE ON KIT LOT 176CBB AND NONREACTIVE ON KIT LOT 191CBB; ONE SAMPLE NONREACTIVE ON BOTH KIT LOTS), (B)(4) (BOTH SAMPLES WERE REACTIVE) AND THE (B)(4) (BOTH SAMPLES WERE POSITIVE). THE AMOUNT OF SAMPLE THAT HAS BEEN PROVIDED TO BIO-RAD WAS INSUFFICIENT FOR MORE EXTENSIVE TESTING. ONE OF THE SAMPLES (#2) IS FROM A PEDIATRIC PATIENT AND THE OTHER IS A REPOSITORY SAMPLE OF UNKNOWN ORIGIN. ALL THREE OF THE (B)(4) KIT LOTS WERE TESTED EXTENSIVELY AT BIO-RAD WITH SEROCONVERSION PANELS; A WORLDWIDE (B)(6) PERFORMANCE PANEL DILUTED 1:100; 90 KNOWN (B)(6) POSITIVE SAMPLES DILUTED 1:100; AND 60 END-STAGE (B)(6) SAMPLES WITH CD4 COUNTS BELOW 90 AND DILUTED 1:100 BEFORE TESTING. IN THIS TESTING, ALL KNOWN POSITIVE SAMPLES WERE HIGHLY REACTIVE WITH ALL KIT LOTS OF (B)(4) AND RESULTS FOR ALL LOTS WERE EQUIVALENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GS HIV-1/HIV-2 PLUS O EIA IVD, EIA MZF BIO-RAD LABORATORIES 191CBB-50

    Patients

    Seq Age Sex Outcome Treatment
    1