BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELITE MICROPLATE SYSTEM

    MDR report key: 1959090 · Received December 15, 2010

    Report

    Report Number
    3022521-2010-00005
    Event Type
    Malfunction
    Date Received
    December 15, 2010
    Date of Event
    October 25, 2010
    Report Date
    November 5, 2010
    Manufacturer
    BIO-RAD LABORATORIES, INC.
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING (B)(6) 2010 SERVICE CALL TO A CUSTOMER SITE FOR THE ELITE MICROPLATE SYSTEM/AUTOMATED MICROPLATE WORKSTATION, IT WAS DETERMINED THAT THE TADM (TOTAL ASPIRATION AND DISPENSE MONITORING) CLOT DETECTION SYSTEM FOR THE INSTRUMENT HAD BEEN TURNED OFF SINCE A SERVICE CALL IN 2007. THE TADM SYSTEM IS INTENDED TO NOTIFY THE USER WHEN A CLOT PREVENTS ASPIRATION OF THE CORRECT VOLUME OF SPECIMEN. WHEN A CLOTTED SPECIMEN IS TESTED ON THE ELITE AND THE TADM IS NOT ENABLED, EITHER THE SAMPLE WILL BE REPORTED AS NEGATIVE OR THE ENTIRE PLATE WILL BE REJECTED. THE ELITE SYSTEM WAS BEING USED FOR HIV ANTIBODY TESTING WITH THE (B)(4) GS (B)(4) PLUS O EIA AT THE TESTING SITE. WITHOUT THIS CLOT DETECTION, SOME SAMPLES MAY HAVE BEEN REPORTED AS (B)(4) NEGATIVE WHEN ADEQUATE SAMPLE VOLUME HAD NOT ACTUALLY BEEN TESTED. SAMPLES THAT MAY HAVE BEEN AFFECTED ARE BEING RETESTED, AND NO FALSE NEGATIVE SAMPLES HAVE BEEN IDENTIFIED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELITE MICROPLATE SYSTEM AUTOMATED MICROPLATE ANALYZER JJE BIO-RAD LABORATORIES, INC. ELITE

    Patients

    Seq Age Sex Outcome Treatment
    1