BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXL800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2689841 · Received August 9, 2012

    Report

    Report Number
    2122870-2012-01670
    Event Type
    Malfunction
    Date Received
    August 9, 2012
    Date of Event
    July 17, 2012
    Report Date
    July 18, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UPON DISCOVERY OF THE BROKEN/BENT ASPIRATE PROBE, THE CUSTOMER REPLACED THE PROBE. UPON COMPLETION OF THE NECESSARY AND VERIFIED REPAIRS, THE INSTRUMENT WAS RETURNED BACK INTO OPERATION. SERVICE WAS DISPATCHED TO THE SITE FOR THIS EVENT. THE FIELD SERVICE ENGINEER (FSE) VERIFIED INSTRUMENT PERFORMANCE AFTER THE REPLACEMENT OF ASPIRATE PROBE. NO ISSUES WERE NOTED BY THE ENGINEER. THE BROKEN ASPIRATE PROBE WAS THE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DISCREPANT THYROID STIMULATING HORMONE (TSH), FREE TOTAL THYROXINE (FRT4), CREATINE KINASE-MB ISOENZYME (CK-MB), CORTISOL, TOTAL THYROXINE (TT4), PROSTATE SPECIFIC ANTIGEN (PSA), T-UPTAKE, FERRITIN, FOLATE WORLD HEALTH ORGANIZATION (FOLW), AND/OR VITAMIN B12 RESULTS WERE GENERATED ON A UNICEL DXL800 ACCESS IMMUNOASSAY SYSTEM FOR MULTIPLE PATIENTS. BECKMAN COULTER INC. ASSESSMENT OF CUSTOMER SUPPLIED DATA INDICATED THE INVOLVEMENT OF FIFTY NINE DISCREPANT ASSAY PATIENT RESULTS. MULTIPLE ADDITIONAL PATIENT INITIAL AND REPEAT ASSAY RESULTS WERE PROVIDED BY THE CUSTOMER, HOWEVER ONLY FIFTY NINE INITIAL PATIENT RESULTS WERE FOUND TO BE ERRONEOUS. THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY HOWEVER THERE WERE NO REPORTS OF ADVERSE EVENT OR SERIOUS INJURY RELATED TO THIS EVENT. UPON REPEAT, VALID ASSAY PATIENT RESULTS WERE GENERATED AND CORRECTED REPORTS WERE ISSUED. BECKMAN COULTER INC. ASSESSMENT OF INSTRUMENT ASSAY PERFORMANCE DATA INDICATED THAT QUALITY CONTROL (QC) RESULTS FOR ALL ASSAYS INVOLVED WERE WITHIN THE CUSTOMER'S ESTABLISHED RANGES FOR THE TIMEFRAME PROVIDED. CALIBRATION CURVES WERE ACCEPTED AS PASSING BY THE CUSTOMER AND HAD ACCEPTABLE PERCENT COEFFICIENTS OF VARIATION (%CV). "WASH COLLAR VACUUM ERRORS" WERE GENERATED DURING THE TIMEFRAME OF THE EVENT. ADDITIONALLY, THE CUSTOMER DISCOVERED A BENT/BROKEN ASPIRATE PROBE NUMBER ONE UPON VISUAL INSPECTION OF THE INSTRUMENT. THESE ISSUES ALERTED THE CUSTOMER TO THE OCCURRENCE OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXL800 ACCESS IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1