BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2233650 · Received September 2, 2011

    Report

    Report Number
    2122870-2011-03176
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    August 5, 2011
    Report Date
    August 5, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLES WERE COLLECTED IN GLASS PLASMA SEPARATOR TUBES, AND WERE CENTRIFUGED AT 3000 RPM FOR 10 MINUTES. CARDIAC LOW-LEVEL ACCUTNI QC WAS OUTSIDE OF THE ESTABLISHED RANGES. UPON REPEAT, IT RECOVERED WITHIN THE ESTABLISHED RANGES. THE CUSTOMER HAD PASSING ACCUTNI CALIBRATIONS ON (B)(6) 2011, BUT A FAILING CALIBRATION ON (B)(6) 2011. THE CUSTOMER HAD A PASSING SYSTEM CHECK PERFORMED ON (B)(6) 2011. THE CUSTOMER HAS A REPEAT PROTOCOL IN PLACE. THE CUSTOMER DOES NOT REPORT OUT HIGH PATIENT RESULTS UNTIL THE SAMPLES ARE RERUN TO CONFIRM ACCURACY. IF SAMPLES ARE STILL HIGH AFTER REPEAT, THE CUSTOMER RUNS THE SAMPLES ON TRIAGE INSTRUMENT, AND REPORTS THE RESULTS. SERVICE WAS DISPATCHED FOR THIS EVENT AND ON-SITE ON (B)(4) 2011. THE FIELD SERVICE ENGINEER (FSE) NOTED THAT THE LUMINOMETER NEEDED TO BE INCREASED TO MATCH LED TARGET VALUE. THE FSE REPLACED VACUUM PUMP BECAUSE IT WAS NOT REACHING THE PRESSURE SPECIFICATIONS. THE FSE PERFORMED A PREVENTIVE MAINTENANCE. QC WAS RUN AND THE RESULTS WERE WITHIN THE ESTABLISHED RANGE. THE CUSTOMER PERFORMED A PRECISION RUN, BUT RESULTS WERE NOT WITHIN THE CUSTOMER'S EXPECTATIONS. THE FSE REPLACED DISPENSE PROBES. THE FSE RAN A SYSTEM CHECK, WHICH PRODUCED RESULTS WITHIN THE SPECIFICATIONS. THE CUSTOMER RAN 8 REP PATIENT RUNS AND 8 REP PROFICIENCY RUNS. THE RESULTS WERE WITHIN THE CUSTOMER'S EXPECTATIONS. ALTHOUGH HARDWARE ISSUES WERE ADDRESSED, NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BEC) CONCERNING NON-REPRODUCIBLE ELEVATED TROPONIN (ACCUTNI) RESULTS GENERATED BY ACCESS 2 IMMUNOASSAY SYSTEM FOR PATIENTS AND QUALITY CONTROLS. THE RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. REPEAT TESTING ON RE-CENTRIFUGED SAMPLES PRODUCED RESULTS WITHIN THE NORMAL REFERENCE RANGE. THE CUSTOMER STATED THIS HAD BEEN HAPPENING FOR SOME TIME. THE CUSTOMER DID NOT PROVIDE SPECIFIC EVENT INFORMATION. THERE WAS NO REPORT OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1