BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXL800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2232151 · Received September 2, 2011

    Report

    Report Number
    2122870-2011-03108
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    August 3, 2011
    Report Date
    August 5, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    LTJ
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS DISPATCHED TO THE SITE ON (B)(6) 2011 FOR THIS EVENT. THE FIELD SERVICE ENGINEER (FSE) PERFORMED PREVENTIVE MAINTENANCE ACTIVITIES ON THE INSTRUMENT. THE FSE PERFORMED INSTRUMENT PERFORMANCE AND PRECISION VERIFICATION ASSESSMENTS. BOTH GENERATED RESULTS WHICH MET INSTRUMENT SPECIFICATIONS. UPON COMPLETION OF VERIFIED REPAIRS THE INSTRUMENT WAS RETURNED INTO SERVICE. A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED TO DATE FOR THIS EVENT. MDRS ASSOCIATED WITH THIS EVENT: 2122870-2011-03106; 2122870-2011-03107; 2122870-2011-03108.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT IMPRECISE HYBRITECH PROSTATE SPECIFIC ANTIGEN (HYB PSA) RESULTS WERE GENERATED FROM A UNICEL DXL800 ACCESS IMMUNOASSAY SYSTEM. THE CUSTOMER INDICATED THIS EVENT HAD OCCURRED FOUR TIMES OVER A TWO WEEK PERIOD HOWEVER, DATA SUPPLIED BY THE CUSTOMER INDICATES THAT THREE PATIENTS WERE INVOLVED IN THIS EVENT ON THREE DIFFERENT DAYS. THIS REPORT IS THREE OF THREE AND REPRESENTS THE IMPRECISE HYB PSA RESULTS GENERATED FOR ONE PATIENT SAMPLE ON (B)(6) 2011. DATA SUPPLIED BY THE CUSTOMER INDICATES THAT THE INITIAL RESULT WAS ELEVATED ABOVE THE NORMAL REFERENCE RANGE FOR THE ASSAY. MULTIPLE SAME-SAMPLE REPEAT RESULTS GENERATED FROM THE SAME INSTRUMENT ALSO RECOVERED ABOVE THE REFERENCE RANGE. COLLECTIVELY THE RESULTS WERE OUTSIDE THE ASSAY'S PRECISION CLAIMS. THE IMPRECISE RESULT(S) WERE REPORTED OUTSIDE OF THE LABORATORY HOWEVER THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR MODIFICATION TO PATIENT TREATMENT ASSOCIATED OR ATTRIBUTED TO THIS EVENT. THE CUSTOMER HAD ORIGINALLY REPORTED ON A FOURTH SET OF PATIENT RESULTS REPRODUCING UNACCEPTABLY. HOWEVER, THIS PATIENT'S RESULTS RECOVERED WITHIN THE STATED ASSAY'S PRECISION CLAIMS, AND HENCE WERE NOT REGARDED AS IMPRECISE. ALL LEVELS OF INSTRUMENT HYB PSA QUALITY CONTROL RESULTS RECOVERED WITHIN CUSTOMER ESTABLISHED SPECIFICATIONS DURING THE TIMEFRAME OF THIS EVENT. THE SAMPLE WAS DRAWN AND SPUN AT A SATELLITE FACILITY AND SHIPPED TO CUSTOMER FOR TESTING. THE INITIAL TESTING WAS FROM THE PRIMARY TUBE AND REPEAT TESTING WAS VIA A SAMPLE CUP. PATIENT SPECIFIC 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 LTJ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 ACCESS HYBRITECH PSA REAGENT