BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2233420 · Received September 2, 2011

    Report

    Report Number
    2122870-2011-03175
    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
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PATIENT RESULTS ARE REPORTED.

    Additional Manufacturer Narrative · 1

    THE SAMPLES WERE COLLECTED IN BD 13 X 75MM TUBES AND CENTRIFUGED FOR 3500 RPM FOR 10 MINUTES. QC IS PERFORMED THREE TIMES A DAY AND WAS WITHIN THE ESTABLISHED RANGES PRIOR TO THE ERRONEOUS RESULTS. THREE LEVELS OF QC AFTER THE ERRONEOUS RESULTS WERE OUT OF SPECIFICATIONS HIGH. A SYSTEM CHECK PERFORMED ON (B)(4) 2011 PRIOR TO THIS EVENT MET THE SPECIFICATIONS. A DIAGNOSTIC SYSTEM CHECK WAS PERFORMED AFTER THE ERRONEOUS RESULTS AND FAILED THE WASHED MEAN AND THE SUBSTRATE RATIO. SERVICE WAS ON SITE ON (B)(4) 2011. THE FIELD SERVICE ENGINEER (FSE) FOUND A PINCHED PERI PUMP TUBING AND A FAULTY SOLENOID WASH VALVE. BOTH PARTS WERE REPLACED. THE FSE PERFORMED A PREVENTIVE MAINTENANCE. ALL VERIFICATION TESTING MET THE SPECIFICATIONS. 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. THE RESULTS WERE REPORTED OUT OF THE LABORATORY, AND WERE QUESTIONED BY THE ER PHYSICIAN AS THE RESULTS WERE NOT FITTING THE CLINICAL PICTURE OF THE PATIENTS. THE CUSTOMER STATED APPROXIMATELY 21 PATIENT SAMPLES WERE ANALYZED DURING THIS EVENT. IT IS NOT KNOWN IF ALL 21 PATIENTS SAMPLES CAME FROM THE ER AND HOW MANY OF THEM WERE ELEVATED. SEVERAL OF THESE PATIENT SAMPLES WERE REPEATED AND PRODUCED RESULTS WITHIN THE NORMAL REFERENCE RANGES. 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