BEUDAMED
    FDA Adverse Event Other Summary report: N

    GENETIC SYSTEMS RLAV EIA

    MDR report key: 704517 · Received April 24, 2006

    Report

    Report Number
    3022521-2006-00002
    Event Type
    Other
    Date Received
    April 24, 2006
    Date of Event
    March 24, 2006
    Report Date
    April 21, 2006
    Manufacturer
    BIO-RAD LABORATORIES
    Product Code
    LRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    BIO-RAD LABORATORIES TECHNICAL SUPPORT RECEIVED A PHONE CALL FROM A CUSTOMER. CUSTOMER STATED THAT THEY PERFORMED A TOTAL OF 3 RUNS USING THE GENETIC SYSTEMS RLAV EIA (AN HIV-1 ANTIBODY EIA) ASSAY ALONG WITH EXTERNAL POSITIVE AND NEGATIVE CONTROLS MANUFACTURED BY BLACKHAWK BIOSYSTEMS INC. 2 OF THE RUNS SHOWED THE EXTERNAL POSITIVE CONTROL WAS NEGATIVE AND 1 RUN THE EXTERNAL POSITIVE CONTROL WAS JUST ABOVE THE CUTOFF. PREVIOUS TO THESE RUNS THE EXTERNAL POSITIVE CONTROL HAD BEEN VALID. TECHNICAL SUPPORT REQUESTED THAT THE CUSTOMER FAX THEIR DATA FOR REVIEW. IN INVESTIGATING THE ISSUE WITH THE CUSTOMER, IT WAS DETERMINED THAT THE TECHNICIANS WERE LEAVING MULTIPLE VIALS OF CONJUGATE CONCENTRATE OF DIFFERENT LOT NUMBERS IN THEIR REFRIGERATOR AND THEY WERE NOT NECESSARILY USING CORRECT LOT-SPECIFIC VIALS WHEN PREPARING THE WORKING CONJUGATE FOR EACH RUN OF THE GENETIC SYSTEMS RLAV EIA KIT. THE CUSTOMER INDICATED THAT THEY HAVE SINCE CORRECTED THIS PRACTICE. PAGE 6 OF THE GENETIC SYSTEMS RLAV EIA PACKAGE INSERT UNDER PRECAUTIONS FOR USERS STATES: -#2 THE ONLY REAGENTS THAT MAY BE USED WITH DIFFERENT LOTS OF THE RLAV EIA OR OTHER GENETIC SYSTEMS TEST KITS ARE THE CHROMOGEN REAGENT, CHROMOGEN DILUENT, WASH SOLUTION CONCENTRATE AND STOPPING SOLUTION. DO NOT MIX ANY OTHER REAGENTS FROM DIFFERENT LOTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENETIC SYSTEMS RLAV EIA IVD, EIA LRM BIO-RAD LABORATORIES * 202YAA-05

    Patients

    Seq Age Sex Outcome Treatment
    1 *