BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXL800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2242276 · Received September 10, 2011

    Report

    Report Number
    2122870-2011-03583
    Event Type
    Malfunction
    Date Received
    September 10, 2011
    Date of Event
    August 23, 2011
    Report Date
    August 23, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED TO THE SITE FOR THIS EVENT. BECKMAN COULTER INC. REVIEW OF A CUSTOMER SUPPLIED INSTRUMENT/REAGENT DRIFT STUDY INDICATES THAT TT3 QUALITY CONTROL (QC) RESULTS DISPLAYED HIGHER THAN NORMAL QC OUT OF RANGE HIGH EVENTS WHEN THE QC ASSESSMENT WAS RUN AT THE END OF THE REAGENT PACK (LESS THAN OR EQUAL TO FIVE TESTS LEFT IN THE REAGENT PACK). IT WAS NOTED THAT THE CUSTOMER UTILIZES A SLIGHTLY TIGHTER QC TOLERANCE THAT PEER GROUP. A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED TO DATE FOR THIS EVENT. MDRS ASSOCIATED WITH THIS EVENT: 2122870-2011-03582; 2122870-2011-03583; 2122870-2011-03584.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT IMPRECISE TRIODOTHYRONINE (TT3) RESULTS WERE GENERATED ON A UNICEL DXL800 ACCESS IMMUNOASSAY SYSTEM FOR THREE PATIENT SAMPLES OUT OF SIXTEEN PATIENT REPEAT TESTS. ACTUAL RESULTS FOR THE THIRTEEN PATIENTS NOT REPORTED IS UNKNOWN AND INFERRED TO BE VALID AND NOT ERRONEOUS. THIS REPORT IS TWO OF THREE AND REPRESENTS THE TT3 RESULTS GENERATED FOR A SECOND PATIENT SAMPLE ON A UNICEL DXL800 ACCESS IMMUNOASSAY SYSTEM ON (B)(6) 2011 WHICH WERE REGARDED AS IMPRECISE. THE INITIAL TT3 RESULT, WHICH WAS WITHIN THE ASSAY'S NORMAL REFERENCE RANGE, WAS REPORTED OUTSIDE OF THE LABORATORY. WHILE THERE IS NO REPORT OF ADVERSE EVENT OR SERIOUS INJURY RELATED TO THIS EVENT, IT IS UNKNOWN WHETHER THERE WAS A CHANGE TO PATIENT MANAGEMENT. UPON REPEAT TESTING ON THE SAME INSTRUMENT, THE TT3 RESULT WAS LOWER AND STILL WITHIN THE ASSAY'S NORMAL REFERENCE RANGE, HOWEVER COLLECTIVELY THE RESULTS DID NOT MEET THE PRECISION CLAIMS OF THE ASSAY. NO PATIENT SPECIFIC INFORMATION, SAMPLE COLLECTION/HANDLING INFORMATION OR ADDITIONAL INSTRUMENT PERFORMANCE INFORMATION WAS 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 ACCESS TOTAL T3 REAGENT