BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSSAY SYSTEM

    MDR report key: 1003403 · Received February 21, 2008

    Report

    Report Number
    2122870-2008-00059
    Event Type
    Malfunction
    Date Received
    February 21, 2008
    Date of Event
    February 5, 2008
    Report Date
    February 21, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    QC IS RUN EACH SHIFT AND WAS WITHIN RANGE PRIOR TO THE EVENT. NO SAMPLES WERE FLAGGED WITH ERRORS AND NO ERRORS WERE POSTED TO THE EVENT LOG. THE SPECIMENS WERE PLASMA TYPE, COLLECTED IN LITHIUM HEPARIN TUBES WITH GEL. THE SAMPLES WERE FULL TUBE DRAWS AND NO SAMPLE QUALITY ISSUES WERE NOTED. THE SPECIMENS WERE NOT RE-CENTRIFUGED BEFORE RE-TESTING. A FIELD SERVICE ENGINEER (FSE) WAS NOT DISPATCHED INITIALLY, AS CUSTOMER DECLINED SERVICE. CUSTOMER CALLED BACK AND REQUESTED SERVICE. THE FSE INSPECTED THE INSTRUMENT AND NO SIGNIFICANT HARDWARE ISSUES WERE FOUND. THE FSE CLEANED WASH TOWER NOZZLES AND CHECKED PIPETTORS #3 AND #4. THE FSE RAN A SPECIAL CLEAN FOR ASPIRATE PROBES, PERFORMED TECHNICAL INFO UPDATE SYSTEM (TIUS) VERIFICATION PROTOCOL AND CONDUCTED DIAGNOSTIC TESTING. ALL VERIFICATION TESTING RESULTS MET PUBLISHED PERFORMANCE SPECIFICATIONS. A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) REGARDING AN ERRONEOUS TROPONIN (ACCU TNI) RESULT THAT WAS GENERATED BY THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM FOR A SINGLE PT SAMPLE. AN INITIAL ACCU TNI RESULT OF 2.92NG/ML WAS REPORTED OUT OF THE LAB. THE SAMPLE WAS RE-TESTED AND REPEATED ACCU TNI RESULT WAS 0.08NG/ML. A CORRECTED REPORT WAS SENT. THE SAMPLE WAS ALSO TESTED ON A DIFFERENT INSTRUMENT IN THE CUSTOMER'S LAB AND A RESULT OF 0.08NG/ML WAS OBTAINED. ON THE NEXT DAY, A FRESH SAMPLE WAS COLLECTED FROM THE PT AND TESTED FOR ACCU TNI, AND A RESULT OF 0.06NG/ML WAS REPORTED OUT OF THE LAB. ADDITIONALLY, CUSTOMER PULLED 4 SAMPLES PREVIOUSLY DRAWN ON PT, BUT CARDIAC ASSAYS HAD NOT BEEN ORDERED. THESE SAMPLES GAVE ACCU TNI RESULTS IN THE RANGE OF 0.05NG/ML - 0.09NG/ML. CUSTOMER STATED THAT THERE WAS NO INJURY, DEATH, CHANGE TO PT TREATMENT, OR INVASIVE TREATMENT ATTRIBUTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXI 800 ACCESS IMMUNOASSSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA