BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2180144 · Received July 27, 2011

    Report

    Report Number
    2122870-2011-02518
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    June 28, 2011
    Report Date
    June 30, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED TO THE SITE FOR THIS EVENT. A DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON (B)(6) 2011 ERRONEOUS THYROGLOBULIN RESULTS, BELOW THE NORMAL REFERENCE RANGE, WERE GENERATED ON AN ACCESS 2 IMMUNOASSAY SYSTEM FOR FOUR PATIENTS. THE INITIAL, ERRONEOUS THYROGLOBULIN RESULTS WERE REPORTED OUTSIDE THE LABORATORY HOWEVER THERE HAVE BEEN NO REPORTS OF DEATHS, SERIOUS INJURIES OR MODIFICATIONS TO PATIENT TREATMENTS ASSOCIATED OR ATTRIBUTED TO THIS EVENT. THE CUSTOMER ELECTED TO PERFORM REPEAT THYROGLOBULIN TESTING WHEN THEY NOTED A SIGNIFICANT RESULT DIFFERENCE FOR PATIENT ONE'S THYROGLOBULIN INITIAL RESULT IN COMPARISON TO A SAME-PATIENT THYROGLOBULIN RESULT GENERATED A MONTH PRIOR. UPON REPEAT ON THE SAME INSTRUMENT, THE THYROGLOBULIN RESULTS FOR THREE OF THE FOUR PATIENTS WERE HIGHER AND WITHIN OR ABOVE THE NORMAL REFERENCE RANGE. THE FOURTH PATIENT SAMPLE SHOWED IMPRECISION BELOW THE NORMAL REFERENCE RANGE. NO OTHER RESULTS WERE QUESTIONED BY THE CUSTOMER BEYOND THESE FOUR PATIENTS. INSTRUMENT THYROGLOBULIN QUALITY CONTROL RESULTS RECOVERED WITHIN THE CUSTOMER'S ESTABLISHED RANGES DURING THE TIMEFRAME OF THIS EVENT. SYSTEM CHECK RESULTS GENERATED PRIOR TO THE EVENT MET ESTABLISHED SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS® 2 IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 ACCESS THYROGLOBULIN REAGENT