BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT AXSYM SYSTEM

    MDR report key: 1920038 · Received December 10, 2010

    Report

    Report Number
    1628664-2010-00470
    Event Type
    Malfunction
    Date Received
    December 10, 2010
    Date of Event
    December 7, 2010
    Report Date
    December 7, 2010
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    PMA / PMN Number
    K950915
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. CONCOMITANT MEDICAL PRODUCTS: CARD CAGE ASSEMBLY LN: 4-37085-02.

    Additional Manufacturer Narrative · 1

    (B)(4). AN ABBOTT FIELD SERVICE REPRESENTATIVE (FSR) INSPECTED THE AXSYM SYSTEM AND FOUND A CLOGGED WASTE MANIFOLD, CAUSING LIQUID WASTE TO BACK UP AND FLOOD THE UPPER LEVELS OF THE AXSYM SYSTEM. LIQUID WASTE DRIPPED OVER THE OPTICS BOARD CAUSING IT TO BURN OUT. THE FSR REPLACED THE MANUAL EJECTOR ASSEMBLY AND THE DAMAGED STEPPER DRIVER ASSEMBLY, CARD CAGE ASSEMBLY, AND OPTICS REGULATOR BOARD. SUBSEQUENT INSTRUMENT OPERATIONS AND TEST RESULTS WERE ACCEPTABLE. THE ABBOTT AXSYM SYSTEM OPERATIONS MANUAL (LIST NUMBER (B)(4)) CONTAINS INFORMATION TO ADDRESS THE CUSTOMER'S CURRENT ISSUE. A REVIEW OF COMPLAINT TRACKING AND TRENDING METRICS WAS PERFORMED AND IDENTIFIED NO ADVERSE TRENDS IN CONJUNCTION WITH THE COMPLAINT ISSUE CURRENTLY UNDER EVALUATION. EVALUATION METHOD: REVIEW OF COMPLAINT TRACKING AND TRENDING; FIELD SERVICE INTERVENTION.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT WHILE THE AXSYM ANALYZER WAS PERFORMING A RUN, ERROR CODE 7022 (TEMP BOARD NOT RESPONDING, COMMUNICATION ERROR) WAS GENERATED ACCOMPANIED BY A "HOT SMELL" AND A SMALL AMOUNT OF SMOKE. THE CUSTOMER POWERED OFF THE ANALYZER, BUT THE "HOT SMELL" PERSISTED. A SERVICE CALL WAS INITIATED. THE ABBOTT FIELD SERVICE ENGINEER (FSE) FOUND THAT FLUID HAD LEAKED AT THE BACK OF THE ANALYZER AND HAD DRIPPED ONTO THE CARD CAGE, SHORTING OUT THE OPTICS BOARD. THE LEAK OCCURRED DUE TO A BUILD UP OF FOLATE SOLIDS, WHICH CLOGGED THE WASTE MANIFOLD. THIS CAUSED THE WASTE TO BACKUP AND FLOOD THE LOWER AND UPPER LEVELS OF THE ANALYZER. NO REPORTS OF EXPOSURE ARE DOCUMENTED IN THE COMPLAINT TEXT. THE FSE REMOVED AND CLEANED THE WASTE MANIFOLD AND ASSOCIATED CONNECTION AND TUBING. THE FSE VISIT ALSO RESULTED IN THE REPLACEMENT OF THE CARD CAGE, OPTICS BOARD AND STEPPER DRIVER. SUBSEQUENT INSTRUMENT OPERATIONS AND TEST RESULTS WERE ACCEPTABLE. THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT AXSYM SYSTEM AUTOMATED IMMUNOASSAY ANALYZER JJE ABBOTT MANUFACTURING, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 PWA, AX OPTICS REG LN: (B)(4)| PWA, AX OPTICS REG LN: (B)(4)