BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXL800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2374643 · Received December 14, 2011

    Report

    Report Number
    2122870-2011-06356
    Event Type
    Malfunction
    Date Received
    December 14, 2011
    Date of Event
    November 24, 2011
    Report Date
    November 27, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS DISPATCHED ON (B)(4) 2011 IN ASSOCIATION WITH THIS EVENT. THE FIELD SERVICE ENGINEER (FSE) DISCOVERED THAT THE ASPIRATE PROBE TUBING WAS MOUNTED TOO SHORT IN THE BRACKET. THE FSE REPLACED AND ADJUSTED THE ASPIRATE PROBE TUBING ACCORDINGLY TO ALLOW FOR FULL TRAVEL OF THE PROBES. THE FSE PERFORMED A ROUTINE SYSTEM CHECK WHICH PASSED WITHIN INSTRUMENT SPECIFICATIONS. UPON COMPLETION OF THE NECESSARY AND VERIFIED REPAIRS, THE INSTRUMENT WAS RETURNED BACK INTO OPERATION. A DEFINITIVE ROOT CAUSE ASSOCIATED WITH THIS EVENT HAS NOT BEEN DETERMINED TO DATE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON (B)(6) 2011, ELEVATED AND ERRATIC CARCINOEMBRYONIC ANTIGEN (CEA) QUALITY CONTROL (QC) RESULTS WERE GENERATED ON A UNICEL DXL800 ACCESS IMMUNOASSAY SYSTEM. THE EVENT WAS DISCOVERED ON THE SAME DAY THAT THE CUSTOMER PERFORMED INSTRUMENT MAINTENANCE. THERE WERE NO PATIENT RESULTS IMPACTED BY THIS EVENT. BECKMAN COULTER INC. ASSESSMENT OF CUSTOMER SUPPLIED INSTRUMENT PERFORMANCE DATA INDICATED THAT CEA QUALITY CONTROL (QC) RESULTS HAD SHIFTED UP ONE TO TWO STANDARD DEVIATIONS ABOVE THE CUSTOMER'S ESTABLISHED MEAN ON (B)(6) 2011 AND (B)(6) 2011. LEVEL TWO AND LEVEL THREE QC RESULTS POSSESSED SEVERAL QUALITY CONTROL POINTS THAT WERE OUTSIDE THE SPECIFICATION BY GREATER THAN TWO STANDARD DEVIATIONS. A ROUTINE SYSTEM CHECK FAILED TO MEET SPECIFICATIONS DUE TO A HIGH WASHED MEAN VALUE AND %COEFFICIENT OF VARIATION VALUE. BECKMAN COULTER INC. TECHNICAL SUPPORT NOTED THAT THE INSTRUMENT ASPIRATE PROBE #3 APPEARED TO HAVE "SLUGS OF FLUID" REMAINING IN THE TUBING. SAMPLE COLLECTION/HANDLING INFORMATION WAS NOT PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXL800 ACCESS IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 ACCESS CEA REAGENT