BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 3212106 · Received July 8, 2013

    Report

    Report Number
    2122870-2013-00600
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    June 9, 2013
    Report Date
    June 10, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) NOTICED MULTIPLE WASH PUMP/VALVE MOTION ERRORS IN THE EVENT LOG OVER THE LAST FEW DAYS. THE FSE REMOVED THE WASH VALVE ROTOR AND STATOR AND REPLACED BOTH PARTS DUE TO WEAR. THE FSE ALSO INSPECTED THE WASH PUMP BELT AND SENSOR; NO ISSUES WERE NOTED. THE FSE PERFORMED A BACKLASH CALIBRATION ON THE WASH PUMP AND NOTICED SOME WETNESS AROUND THE WASH TOWER NOZZLE. THE FSE REMOVED THE WASH TOWER NOZZLE O-RINGS FOR INSPECTION; NO ISSUES WERE NOTED. A ROUTINE SYSTEM CHECK WAS THEN PERFORMED WHICH FAILED DUE TO THE UNWASHED PORTION BEING OUT OF SPECIFICATIONS. THE FSE ALSO PERFORMED A VOLUME CHECK ON THE MAIN PIPETTOR AND DISCOVERED BUBBLES ENTERING THE SYSTEM UPON DISPENSE AND REPLACED THE PRECISION VALVE UPPER AND LOWER SEALS. VERIFICATION TESTING (ROUTINE SYSTEM CHECK, HIGH SENSITIVITY SYSTEM CHECK AND ASSAY QUALITY CONTROL) WAS PERFORMED AND ALL TESTS PASSED WITHIN INSTRUMENT SPECIFICATIONS. NO FURTHER MOTION ERRORS WERE OBSERVED. SERVICE ACTIVITY PERFORMED WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS AND WAS RETURNED TO NORMAL OPERATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED RECEIVING WASH VALVE PUMP MOTION ERROR AND ERRONEOUSLY ELEVATED TROPONIN I (ACCESS ACCUTNI) RESULT, WITHIN THE RISK STRATIFICATION, FOR ONE PATIENT DURING AN INSTRUMENT-TO-INSTRUMENT CORRELATION STUDY INVOLVING THE ACCESS 2 IMMUNOASSAY SYSTEM USED IN CONJUNCTION WITH THE ACCESS ACCUTNI ASSAY. AN INITIAL RESULT OF 0.33 NG/ML WAS OBTAINED AND REPORTED OUT OF THE LABORATORY. THE CUSTOMER RETESTED THE SAMPLE ON THE ORIGINAL INSTRUMENT AND ON AN ALTERNATE ACCESS 2 SYSTEM AND OBTAINED RESULTS OF 0.02 NG/ML AND 0.02 NG/ML WITHIN THE NORMAL REFERENCE RANGE, RESPECTIVELY. AN AMENDED REPORT WAS ISSUED TO THE HOSPITAL. THERE HAS BEEN NO REPORT OF PATIENT CONSEQUENCE OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. THE PATIENT ALSO HAD A SECOND SAMPLE DRAWN AND ANALYZED WHICH RESULTED WITHIN THE NORMAL REFERENCE RANGE. THE RETEST RESULTS WERE IN BETTER ALIGNMENT WITH THE PATIENT¿S CLINICAL HISTORY. SERVICE WAS REQUESTED AND A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309854 ACCESS® 2 IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE MMI BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1