BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 1200383 · Received October 15, 2008

    Report

    Report Number
    2122870-2008-00320
    Event Type
    Other
    Date Received
    October 15, 2008
    Date of Event
    September 19, 2008
    Report Date
    October 15, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLES WERE PLASMA AND WERE COLLECTED IN LITHIUM HEPARIN PST TUBES. THE SAMPLE FROM PATIENT NUMBER 1 APPEARED CLOUDY. QC WAS WITHIN SPECIFICATIONS BEFORE AND AFTER THE ERRONEOUS RESULTS. CUSTOMER REPEATED QC AND PATIENT SAMPLES THAT RESULTED DURING THE SAME TIME FRAME. ALL RESULTS REPEATED AND QC WAS WITHIN SPECIFICATIONS. A FIELD SERVICE ENGINEER (FSE) WAS ON SITE IN 2008: FSE PERFORMED A PM (PREVENTIVE MAINTENANCE THAT WAS SCHEDULED TO BE DONE. FSE VERIFIED THE SAMPLE PROBE ALIGNMENTS AND PERFORMED CARRYOVER TESTING AND SYSTEM CHECK, ALL PASSED WITHIN SPECIFICATIONS. FSE VERIFIED REPAIR PER ESTABLISHED PROCEDURES. 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 ERRONEOUSLY ELEVATED ACCUTNI RESULTS GENERATED BY THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM FOR TWO PATIENTS. A PATIENT SAMPLE WHEN TESTED FOR ACCUTNI GAVE A RESULT OF 10NG/ML AND UPON REPEAT THE RESULT WAS IN THE "NORMAL RANGE". THE EXACT RESULTS HOWEVER, WERE NOT SUPPLIED. UPON REPEAT ON A DIFFERENT INSTRUMENT, THIS SAMPLE GAVE A RESULT OF 0.01 (UNITS NOT SUPPLIED). ANOTHER PATIENT'S SAMPLE WHEN TESTED GAVE A RESULT OF 4.39 NG/ML AND WHEN RE-TESTED AFTER RE-SPINNING, IT GAVE A RESULT OF 0.06NG/ML. THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. PATIENT NUMBER TWO WAS SENT TO THE CRITICAL CARE UNIT (CCU) BUT NO INVASIVE PROCEDURES WERE PERFORMED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA