BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 2891912 · Received December 31, 2012

    Report

    Report Number
    2122870-2012-02038
    Event Type
    Malfunction
    Date Received
    December 31, 2012
    Date of Event
    December 3, 2012
    Report Date
    December 3, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) NOTED TROPONIN FLIER WHEN PERFORMED TESTING USING WASH BUFFER AS A SAMPLE. THE FSE NOTED MICRO BUBBLES IN THE WASH PUMP THAT WAS CAUSING INCONSISTENT WASHING OF THE UNBOUND ANALYTE WITHIN THE REACTION VESSEL. THE FSE DETERMINED THE WASH VALVE STATOR AND ROTOR WERE NOT SEATED PROPERLY WHICH WAS CAUSING THE MICRO BUBBLES WITHIN THE WASH PUMP. THE FSE REMOVED, CLEANED, AND PROPERLY RE-ASSEMBLED THE WASH VALVE AND NOTED NO FURTHER MICRO BUBBLES WITHIN THE WASH PUMP UPON INSTRUMENT PRIMING. THE FSE ALSO PERFORMED MIXER PULLEY REPLACEMENT AND THERMAL HARDWARE MODIFICATIONS. SERVICE ACTIVITY PERFORMED WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS. FURTHER REVIEW OF THE CUSTOMER-SUPPLIED DATA INDICATES LEVEL 2 QUALITY CONTROL (QC) RESULTS WERE OUT OF RANGE ON (B)(4) 2012. LEVEL 3 QC RESULTS WERE OUT OF RANGE ON (B)(4) 2012. HOWEVER, REPEAT RESULTS FOR ALL WERE WITHIN THE LABORATORY'S ESTABLISHED RANGES. ADDITIONAL SYSTEM PARAMETERS (INCLUDING CALIBRATION CURVES AND SYSTEM CHECKS) WERE PERFORMING WITHIN SPECIFICATIONS. THE CUSTOMER CONFIRMED THERE WERE NO ERRORS IN THE ANALYZER'S EVENT LOG AT THE TIME OF THE TESTING. ALL RELATED MEDWATCH REPORTS ASSOCIATED WITH THIS EVENT: 2122870-2012-02035, 2122870-2012-02036, 2122870-2012-02037, 2122870-2012-02038.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ERRONEOUSLY ELEVATED TROPONIN I (ACCESS ACCUTNI) RESULTS, WITHIN THE RISK STRATIFICATION AND ABOVE THE ACUTE MYOCARDIAL INFARCTION (AMI) LIMIT FOR MULTIPLE PATIENTS, ON SEPARATE DAYS, INVOLVING THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. THE PATIENT SAMPLES WERE REPEATED ON THE ALTERNATE UNICEL DXC 600I SYSTEM AND RECOVERED LOWER RESULTS WITHIN A DIFFERENT CLINICAL CATEGORY. THE CUSTOMER STATED THE LABORATORY'S CRITICAL CUTOFF IS GREATER THAN 0.6 NG/ML. THE ERRONEOUS RESULTS WERE RELEASED OUT OF THE LABORATORY AND AMENDED REPORTS WERE ISSUED. IT IS UNKNOWN IS PATIENT TREATMENT IS IMPACTED. THERE HAS BEEN NO REPORT OF PATIENT CONSEQUENCE TO DATE. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT. THIS IS REPORT FOUR OF FOUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE MMI BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1