BEUDAMED
    FDA Adverse Event Other Summary report: N

    GENETIC SYSTEMS HIV-1/HIV-2 PLUS O EIA

    MDR report key: 687619 · Received March 10, 2006

    Report

    Report Number
    3022521-2006-00001
    Event Type
    Other
    Date Received
    March 10, 2006
    Date of Event
    February 24, 2006
    Report Date
    March 9, 2006
    Manufacturer
    BIO-RAD LABORATORIES, INC.
    Product Code
    MZF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IN 2/2006, BIO-RAD LABORATORIES TECHNICAL SUPPORT RECEIVED A PHONE CALL FROM A CUSTOMER. CUSTOMER CALLED STATING THAT ONE OF THE TECHNICIANS WAS RUNNING THE GENETIC SYSTEM HIV-1/HIV-2 PLUS O EIA ASSAY WHEN THEY ENCOUNTERED A PLATE WASHER INTERRUPTION THAT WARRANTED REMOVAL OF THE MICROWELL PLATE. THE TECHNICIAN ABORTED THE RUN AND ATTEMPTED TO REMOVE THE PLATE, BUT DID SO WITHOUT WEARING GLOVES. THE PLATE CONTAINED HUMAN SERUM AND/OR PLASMA, AS WELL AS, SAMPLE DILUENT AND WASH BUFFER (TEST KIT COMPONENTS) IN THE WELLS WHICH HAD OVERFLOWED DUE TO THE WASHER INTERRUPTION. THE TECHNICIAN REPORTS THAT SHE WAS WEARING HER LAB COAT BUT NO GLOVES. BY NOT WEARING GLOVES THE TECHNICIAN MAY HAVE BEEN EXPOSED TO POTENTIALLY INFECTIOUS HUMAN SERUM AND/OR PLASMA. THE GENETIC SYSTEMS HIV-1/HIV-2 PLUS O EIA PACKAGE INSERT, SECTION 5, PAGE 6, #5 STATES "WEAR PROTECTIVE CLOTHING AND DISPOSABLE GLOVES WHILE HANDLING THE KIT REAGENTS AND CLINICAL SPECIMENS. WASH HANDS THOROUGHLY AFTER PERFORMING TEST".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENETIC SYSTEMS HIV-1/HIV-2 PLUS O EIA IVD, EIA MZF BIO-RAD LABORATORIES, INC. * 241YBB-05

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN