BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXL800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2563824 · Received May 8, 2012

    Report

    Report Number
    2122870-2012-01311
    Event Type
    Malfunction
    Date Received
    May 8, 2012
    Date of Event
    April 10, 2012
    Report Date
    April 15, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS DISPATCHED ON (B)(4) 2012 TO THE SITE FOR THIS EVENT. THE FIELD SERVICE ENGINEER (FSE) REPLACED THE ASPIRATE PROBE DRAIN TUBING. THE FSE PERFORMED A ROUTINE SYSTEM CHECK WHICH PASSED WITHIN INSTRUMENT SPECIFICATIONS. THE CUSTOMER PERFORMED A PRECISION STUDY FOR THE ESTRADIOL ASSAY WHICH PASSED WITHIN SPECIFICATIONS. UPON COMPLETION OF THE NECESSARY AND VERIFIED REPAIRS, THE INSTRUMENT WAS RETURNED BACK INTO OPERATION. A DEFINITIVE CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE. ASSOCIATED MDRS: 2122870-2012-01244, 2122870-2012-01245, 2122870-2012-01311.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ERRONEOUS ESTRADIOL RESULTS WERE GENERATED FROM AN UNICEL DXI800 ACCESS IMMUNOASSAY SYSTEM FOR MULTIPLE PATIENT SAMPLES. BECKMAN COULTER INC. ASSESSMENT OF CUSTOMER SUPPLIED DATA INDICATED THAT HIGHER THAN EXPECTED ESTRADIOL RESULTS WERE GENERATED FOR THREE PATIENTS WHICH, UPON REPEAT ON THE SAME INSTRUMENT, GENERATED LOWER REPEAT RESULTS. COLLECTIVELY THE RESULTS EXCEEDED THE PRECISION CLAIMS OF THE ASSAY. THIS REPORT REPRESENTS THE HIGHER THAN EXPECTED, IMPRECISE ESTRADIOL RESULT GENERATED ON (B)(4) 2012. THE ERRONEOUS ESTRADIOL RESULT WAS RELEASED FROM THE LABORATORY HOWEVER THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR MODIFICATION TO PATIENT TREATMENT ASSOCIATED OR ATTRIBUTED TO THIS EVENT. THE ESTRADIOL REAGENT AND CALIBRATOR LOTS ASSOCIATED WITH THIS EVENT WERE 120223 AND 119829 RESPECTIVELY. NO OTHER PATIENT RESULTS WERE IN QUESTION AS PART OF THIS EVENT. BECKMAN COULTER INC. ASSESSMENT OF INSTRUMENT/ASSAY PERFORMANCE INFORMATION INDICATED THAT ESTRADIOL QUALITY CONTROL (QC) RESULTS ON THE DAY OF THE EVENT RECOVERED WITHIN ONE TO TWO STANDARD DEVIATIONS FROM CUSTOMER'S ESTABLISHED MEANS. THERE WAS EVIDENCE OF SPORADIC ESTRADIOL QC IMPRECISION DURING THE TIMEFRAME OF THE EVENT. THE ESTRADIOL CALIBRATION CURVES FAILED ON BOTH (B)(4) 2012 DUE TO SUPPRESSED CURVES WHICH PRODUCED "BAD FIT" ERRORS. THE CUSTOMER ATTEMPTED A SECOND CALIBRATION ON (B)(4) 2012 WITH A NEW CALIBRATOR LOT (LOT # 123472) WHICH PASSED WITH ACCEPTABLE RLUS (RELATIVE LIGHT UNITS) AND PERCENT COEFFICIENTS OF VARIATION (%CV) COMPARED TO IN-HOUSE DATA. A ROUTINE SYSTEM CHECK PERFORMED PRIOR TO THE EVENT PASSED WITHIN INSTRUMENT SPECIFICATIONS. BECKMAN COULTER INC. ASSESSMENT OF INSTRUMENT/ASSAY PERFORMANCE INFORMATION INDICATED THAT PRECISION TESTING ON REAGENT PIPETTOR NUMBER FOUR AND NUMBER ONE (USING BOTH THE LOW LEVEL AND HIGH LEVEL ESTRADIOL QC MATERIAL) FAILED AT THE LOW LEVEL DUE TO AN ELEVATED %CV HOWEVER PASSED AT THE HIGH LEVEL ON (B)(4) 2012. A PRECISION TEST UTILIZING ALPHA-FETOPROTEIN PASSED WELL WITHIN THE PRECISION SPECIFICATIONS OF THE ASSAY. PATIENT SAMPLE HANDLING AND COLLECTION INFORMATION WAS NOT PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXL800 ACCESS IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1