BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY ANALYZER

    MDR report key: 2944707 · Received February 5, 2013

    Report

    Report Number
    2122870-2013-00058
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Date of Event
    January 10, 2013
    Report Date
    January 10, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTING OBTAINING ERRONEOUSLY ELEVATED RESULTS ON MULTIPLE ASSAYS FOR FIVE PATIENTS INVOLVING THE ACCESS 2 IMMUNOASSAY ANALYZER. THE CUSTOMER STATED THAT "SAMPLE COUNTS OUTSIDE LIMITS" ERRORS WERE POSTED TO THE ANALYZER'S EVENT LOG AT THE TIME THAT THE RESULTS WERE GENERATED. NO ERRONEOUS RESULTS WERE GENERATED AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. THE CUSTOMER INDICATED THAT ALL PATIENT SAMPLES WILL BE REPEATED ON THE LABORATORY'S ALTERNATE ACCESS 2 ANALYZER TO VERIFY THE RESULTS. TO DATE, THE CUSTOMER HAS NOT CALLED BECKMAN COULTER FOR ANY ADDITIONAL ERRONEOUS OR QUESTIONED PATIENT RESULTS. THE CUSTOMER REPORTED THAT THEY ARE USING A FULL BOTTLE OF SUBSTRATE IN AROUND AN HOUR AND FORTY MINUTES. ONE FULL BOTTLE OF SUBSTRATE CAN BE USED TO RUN A TOTAL OF 600 TESTS. THE ACCESS 2 REFERENCE MANUAL STATES THAT THE SYSTEM CAN PROCESS UP TO 100 TESTS PER HOUR FOR ONE STEP ASSAYS, OR UP TO 50 TESTS PER HOUR FOR TWO STEP ASSAYS. THE CUSTOMER HAD ALSO INDICATED THAT THE REACTION VESSELS (RVS) WERE FULL WHEN COMING OUT OF THE INSTRUMENT. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND REPLACED THE SUBSTRATE PUMP. THE REPAIR WAS VERIFIED PER ESTABLISHED PROCEDURES AND RESULTS MET PUBLISHED SPECIFICATIONS. FAILURE MODE WAS HARDWARE MALFUNCTION AND ISSUE WAS RESOLVED FOLLOWING SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48112 ACCESS® 2 IMMUNOASSAY ANALYZER ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1