BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXL800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2233748 · Received September 3, 2011

    Report

    Report Number
    2122870-2011-03371
    Event Type
    Malfunction
    Date Received
    September 3, 2011
    Date of Event
    August 10, 2011
    Report Date
    August 10, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED TO THE SITE FOR THIS EVENT THE SAMPLE IN QUESTION WAS FORWARDED TO BECKMAN COULTER INC. FOR ADDITIONAL EVALUATION AND INVESTIGATION. THIS PROCESS IS ONGOING.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AN ERRONEOUS FREE TOTAL THYROXINE (FRT4) RESULT WAS GENERATED ON A UNICEL DXL800 ACCESS IMMUNOASSAY SYSTEM FOR ONE PATIENT SAMPLE. THE INITIAL FRT4 RESULT, WHICH WAS WITHIN THE NORMAL REFERENCE RANGE, WAS NOT REPORTED OUT OF THE LABORATORY AND WAS QUESTIONED BY THE CUSTOMER AS IT DID NOT MATCH THE PATIENT'S CLINICAL PICTURE. THERE WAS NO DEATH, SERIOUS INJURY OR MODIFICATION TO PATIENT TREATMENT ASSOCIATED OR ATTRIBUTED TO THIS EVENT. THE TEST SAMPLE WAS FORWARDED TO BECKMAN COULTER INC. FOR ADDITIONAL TESTING AND INVESTIGATION. INSTRUMENT FRT4 QUALITY CONTROL RESULTS RECOVERED WITHIN THE CUSTOMER'S ESTABLISHED SPECIFICATION RANGE DURING THE TIMEFRAME OF THE EVENT. THE SAMPLE WAS DRAWN INTO A SST TUBE AND CENTRIFUGED PRIOR TO TESTING. THE SAMPLE WAS NO MORE THAT 4 HOURS OLD AT THE TIME OF TESTING AND WAS RETAINED AT ROOM TEMPERATURE.

    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 FREE T4 REAGENT