BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 4191479 · Received October 22, 2014

    Report

    Report Number
    2122870-2014-00718
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Date of Event
    September 24, 2014
    Report Date
    September 24, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RETURN TO THE CUSTOMER SITE, THE FSE NOTED A PREVENTATIVE MINOR WAS DUE ON THE INSTRUMENTS. THE FSE COMPLETED A PREVENTATIVE MAINTENANCE AND RAN A PASSING HIGH SENSITIVITY SYSTEM CHECK AND 20 REPLICATE PRECISION RUN. ASSOCIATED MDRS: 2122870-2014-00707, 2122870-2014-00708.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING NON-REPRODUCIBLE TROPONIN (ACCUTNI+3) RESULTS ON AN ACCESS 2 IMMUNOASSAY SYSTEM FOR 6 PATIENTS ON (B)(6) 2014. THE CUSTOMER STATED THAT THE RESULTS WERE NOT REPORTED OUT OF THE LABORATORY AND THERE WAS NO CHANGE OR IMPACT TO PATIENT TREATMENT. AFTER OBTAINING THE NON-REPRODUCIBLE RESULTS, THE CUSTOMER RAN A SYSTEM CHECK WHICH FAILED THE WASHED, WASHED PERCENT COEFFICIENT OF VARIATION (%CV) AND WASH EFFICIENCY PORTIONS. A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS ON SITE ON (B)(6) 2014 TO EVALUATE THE INSTRUMENT. THE FSE VERIFIED THE VOLUME CHECKS AND ASPIRATION, ULTRASONICS AND PIPETTOR TEMPERATURE. THE FSE ADJUSTED THE PIPETTOR TEMPERATURE ONE DEGREE HIGHER; AND PERFORMED A PASSING SYSTEM CHECK, RECALIBRATED ACCUTNI+3 AND PERFORMED A 3 REPLICATE PRECISION RUN. THE FSE PLANNED TO RETURN ON (B)(6) 2014 TO COMPLETE THE VERIFICATION TESTING. PRIOR TO THE FSE'S RETURN, THE CUSTOMER OBTAINED NON-REPRODUCIBLE TROPONIN AND CREATINE KINASE MB (CK-MB) RESULTS FOR TWO (2) PATIENTS ON (B)(6) 2014. ONE PATIENT RESULT WAS REPORTED OUT OF THE LABORATORY AND AN AMENDED REPORT WAS LATER RELEASED. THE CUSTOMER WAS NOT AWARE OF ANY CHANGE OR IMPACT TO PATIENT TREATMENT. THIS REPORT IS RELATED TO RESULTS GENERATED ON (B)(6) 2014. SAMPLES WERE DRAWN IN LITHIUM HEPARIN TUBES AND WERE CENTRIFUGED FOR FIVE (5) MINUTES AT 3500 ROTATIONS PER MINUTE (RPM).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672957 ACCESS 2 IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1