BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DSI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2243987 · Received August 19, 2011

    Report

    Report Number
    2122870-2011-02962
    Event Type
    Malfunction
    Date Received
    August 19, 2011
    Date of Event
    August 26, 2008
    Report Date
    August 27, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2008, THE FIELD SERVICE ENGINEER (FSE) HAD PERFORMED ALL HARDWARE VERIFICATION TESTING, INCLUDING SYSTEM CHECK AND PRECISION TEST. THE FSE CHECKED PRECISION ON THE PIPETTORS. ALL TESTS PASSED SUCCESSFULLY. ON (B)(6) 2008, THE FSE PERFORMED CARRYOVER TESTING ON THE SAMPLE PROBE, WHICH SUCCESSFULLY PASSED. THE FSE ASSISTED THE CUSTOMER IN SETTING UP AUTO-REFLEX PROTOCOL ON ALL TROPONINS AND CREATINE KINASE-MB (CK-MB) RESULTS TO AID IN PREVENTING ERRONEOUS RESULTS. NO HARDWARE ISSUES WERE IDENTIFIED. THE CUSTOMER HAD BEEN EXPERIENCING ISSUES WITH DISCREPANT RESULTS AND INVESTIGATED ON SAMPLE HANDLING. THE CUSTOMER NOTICED THE PRESENCE OF FIBRIN IN MANY OF THE SAMPLES LOADED ONTO THE INSTRUMENT. IN AN EFFORT TO REDUCE THE FIBRIN IN THE SAMPLES, THE CUSTOMER INCREASED CENTRIFUGATION TIME FROM 5 TO 10 MINUTES - SAMPLE IMPROVEMENT WAS NOT OBSERVED. THE CUSTOMER SUSPECTED PRE-ANALYTICAL ISSUES AND TRAINED THE STAFFED PHLEBOTOMISTS TO INVERT THE TUBES 10 TIMES AND ENSURE TUBES ARE FULL IN ORDER TO OBTAIN ACCURATE TEST RESULTS. THE CUSTOMER STATED THE UNIT WAS IN NORMAL OPERATION. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN JANUARY 1, 2008 AND OCTOBER 23, 2010 FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN ELEVATED CREATINE KINASE-MB (CK-MB) RESULT FOR ONE PATIENT INVOLVING UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. THE SAMPLE WAS RETESTED ON ACCESS 2 IMMUNOASSAY SYSTEM AND PRODUCED A RESULT WITHIN THE NORMAL REFERENCE RANGE. THE ELEVATED RESULT WAS RELEASED OUT OF THE LABORATORY. THERE WAS NO REPORT OF PATIENT INJURY OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. THE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DSI 800 ACCESS IMMUNOASSAY SYSTEM JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR ACCESS CK-MB| ACCESS 2 IMMUNOASSAY SYSTEM