BEUDAMED
    FDA Adverse Event Other Summary report: N

    GENETIC SYSTEMS RLAV EIA

    MDR report key: 960531 · Received December 6, 2007

    Report

    Report Number
    3022521-2007-00004
    Event Type
    Other
    Date Received
    December 6, 2007
    Date of Event
    November 7, 2007
    Report Date
    December 6, 2007
    Manufacturer
    BIO-RAD LABORATORIES
    Product Code
    LRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSIONS: THE ASSAYS WERE VALID PER THE PACKAGE INSERT CRITERIA ACROSS EACH OF THE KIT LOTS TESTED. SAMPLE TESTED REACTIVE IN DUPLICATE ON ALL FIVE LOTS OF RLAV EIA AND POSITIVE ON HIV-1 WESTERN BLOT.

    Description of Event or Problem · 1

    BIO-RAD LABORATORIES TECHNICAL SUPPORT RECEIVED A CALL IN 2007 REGARDING 2 NON REACTIVE PT RESULTS WHILE RUNNING THE GENETIC SYSTEMS RLAV EIA TEST KIT USING A 4 PLATE SYSTEM CALLED THE EVOLIS. PT #1 WAS INFORMED OF THE NON REACTIVE RESULT. THE SECOND PT HAD ALREADY LEFT BEFORE BEING INFORMED OF HIS RESULTS. THEIR BLOOD WORK HAD PREVIOUSLY BEEN TESTED AT THE STATE LAB WHERE THE RESULTS WERE POSITIVE. PT #1 WAS REDRAWN AND RETESTED, AND THE RESULT FROM THIS RETEST WAS POSITIVE. BIO-RAD LABORATORIES TECHNICAL SUPPORT REQUESTED THAT A SAMPLE FROM THE INDIVIDUAL BE SENT TO BIO-RAD LABORATORIES PRODUCT SUPPORT FOR TESTING. THE CUSTOMER STATED THAT SINCE PT #2 IS NO LONGER THERE, AUTHORITIES ARE ATTEMPTING TO LOCATE HIM TO REQUEST HE COME IN FOR RETESTING. HOWEVER, THE RETESTING OF THIS INDIVIDUAL WOULD BE DONE AT THE STATE LAB SO SHE WOULD NOT HAVE ACCESS TO THESE RESULTS. THE EVOLIS INSTRUMENT IS USED FOR PIPETTING OF SAMPLES AND REAGENTS, AND PERFORMING FUNCTIONS NECESSARY TO COMPLETE PROCESSING OF MICROPLATE ASSAYS. WITH EACH PT SAMPLE TUBE, THE CUSTOMER RECEIVES 3X5 CARDS WITH THE PT NAME, ACCESSION NUMBER AND LIST OF TESTS REQUESTED. THE 3X5 CARDS ARE PLACED IN THE SAME ORDER AS THE SPECIMEN TUBES AND USED TO MANUALLY ENTER THE ACCESSION NUMBERS AND THE REQUESTED TESTS INTO THE EVOLIS INSTRUMENT. CUSTOMER STATED THAT THE 2 FALSE NEGATIVE SAMPLES WERE NOT RUN ON THE SAME PLATE. TESTING PERFORMED BY BIO-RAD LABORATORIES PRODUCT SUPPORT ON 5 LOT NUMBERS OF THE GENETIC SYSTEM RLAV EIA ASSAY AND GS HIV-1 WESTERN BLOT, AS WELL AS TESTING PERFORMED ON THE EVOLIS INSTRUMENT, INDICATES A POSSIBILITY THAT THE 2 FALSE NEGATIVE RESULTS ARE DUE TO A SAMPLE MIX-UP. BIO-RAD LABORATORIES' CONCLUSION IS THAT THE CUSTOMER'S CURRENT PRACTICE OF MANUALLY ENTERING THE PT ID NUMBER, INSTEAD OF USING A BARCODE SYSTEM, AS RECOMMENDED BY BIO-RAD LABORATORIES, LEAD TO A SAMPLE MIX-UP AND RESULTED IN THE FALSE NEGATIVE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENETIC SYSTEMS RLAV EIA IVD, EIA LRM BIO-RAD LABORATORIES 170BAA-05

    Patients

    Seq Age Sex Outcome Treatment
    1 YR