BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXL800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2514823 · Received April 3, 2012

    Report

    Report Number
    2122870-2012-00882
    Event Type
    Malfunction
    Date Received
    April 3, 2012
    Date of Event
    March 9, 2012
    Report Date
    March 9, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS DISPATCHED TO THE SITE ON (B)(4) 2012 FOR THIS EVENT. THE FIELD SERVICE ENGINEER (FSE) CLEANED BOTH THE INTERIOR AND EXTERIOR OF THE INSTRUMENT. THE FSE PERFORMED AN INSTRUMENT MODIFICATION ASSOCIATED WITH ASPIRATE/DISPENSE TUBE ROUTING AND INSTALLED THE NEW STYLE MIXER/GRIPPERS. THE FSE VERIFIED THE NECESSARY ALIGNMENTS AND PERFORMED VERIFICATION TESTING AND A QUALITY CONTROL ASSESSMENT WHICH BOTH GENERATED ACCEPTABLE RESULTS. A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED TO DATE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A HIGHER THAN EXPECTED HYBRITECH PROSTATE SPECIFIC ANTIGEN (HYB-PSA) INITIAL RESULT, AND IMPRECISE HYB-PSA RESULTS, WERE GENERATED FROM AN UNICEL DXL800 ACCESS IMMUNOASSAY SYSTEMS FOR ONE PATIENT SAMPLE. THE HYB-PSA RESULT, WHICH WAS WITHIN THE NORMAL REFERENCE RANGE OF THE ASSAY, WAS REPORTED OUTSIDE OF THE LABORATORY AND WAS QUESTIONED AS IT DID NOT MATCH THE PATIENT'S CLINICAL HISTORY. THERE WAS NO DEATH, SERIOUS INJURY OR MODIFICATION TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. BECKMAN COULTER INC. ASSESSMENT OF CUSTOMER SUPPLIED DATA INDICATED THAT MULTIPLE REPEAT TESTS ON THE SAME AS WELL AS ANOTHER INSTRUMENT, GENERATED REPEAT RESULTS WHICH WERE LOWER, STILL WITHIN THE ASSAY'S NORMAL REFERENCE RANGE, AND BETTER MATCHED THE PATIENT'S CLINICAL PRESENTATION. COLLECTIVELY THE RESULTS WERE OUTSIDE OF THE ASSAY'S STATED PRECISION CLAIM. NONE OF THE HYB-PSA RESULTS GENERATED FROM THE ALTERNATE INSTRUMENT HAVE BEEN QUESTIONED AS ERRONEOUS OR IMPRECISE. THE CUSTOMER PROVIDED ADDITIONAL PATIENTS' RESULTS HOWEVER THESE RESULTS ARE NOT IN QUESTION AS PART OF THIS EVENT. THE SAMPLE WAS A FULL DRAW COLLECTED IN A PLASTIC TUBE. IT WAS INVERTED, ALLOWED TO CLOT, AND CENTRIFUGED PRIOR TO TESTING AND WAS STORED REFRIGERATED BETWEEN TESTING. THE SAMPLE WAS NORMAL IN APPEARANCE WITH NO VISIBLE IRREGULARITIES. BECKMAN COULTER INC. ASSESSMENT OF CUSTOMER SUPPLIED INSTRUMENT ASSAY PERFORMANCE DATA INDICATED THAT BOTH LEVELS OF HYB-PSA QUALITY CONTROL (QC) RESULTS DURING THE TIMEFRAME OF THE EVENT WERE WITHIN TWO STANDARD DEVIATIONS OF THE CUSTOMER'S ESTABLISHED MEANS. INSTRUMENT ASSAY CALIBRATIONS PERFORMED PRIOR TO, AND ON THE DAY OF THE EVENT, WERE ACCEPTED AS PASSING AND POSSESSED ACCEPTABLE PERCENT COEFFICIENTS OF VARIATION (%CV). NO ERROR MESSAGES WERE POSTED TO THE INSTRUMENT'S EVENT LOG DURING THE TIMEFRAME OF THIS EVENT. A FIVE THOUSAND AND TEN THOUSAND TEST COUNT MAINTENANCE PROCEDURE HAD BEEN PERFORMED PRIOR TO THE EVENT. THE CUSTOMER PERFORMED A TWENTY REPLICATE PRECISION TEST USING BOTH LEVEL ONE AND THE LEVEL THREE HYB-PSA QC MATERIALS. BOTH PRECISION TESTS PASSED WITH GOOD %CVS AND WITHIN THE ASSAY'S STATED PRECISION CLAIM.

    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 ACCESS HYBRITECH PSA