BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 1960013 · Received January 13, 2011

    Report

    Report Number
    2122870-2011-00058
    Event Type
    Injury
    Date Received
    January 13, 2011
    Date of Event
    October 27, 2010
    Report Date
    December 16, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SPECIMEN IS NOT AVAILABLE FOR TESTING. SERVICE WAS NOT DISPATCHED FOR THIS EVENT. A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED TO DATE FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) REGARDING THYROGLOBULIN RESULTS IN THE NORMAL REFERENCE RANGE GENERATED BY THE ACCESS 2 IMMUNOASSAY SYSTEM FOR ONE PATIENT THAT DID NOT FIT THE CLINICAL PICTURE OF THE PATIENT. PREVIOUS THYROGLOBULIN RESULTS ON TWO ALTERNATE METHODS WERE BELOW THE NORMAL REFERENCE RANGE. THE RESULTS WERE REPORTED OUT OF THE LAB. THE PATIENT HAS TO REPEAT SEVERAL EXAMS DUE TO THE HIGHER THAN EXPECTED THYROGLOBULIN RESULTS. EXACT TREATMENTS OR TESTS THAT HAD TO BE REPEATED WERE NOT SUPPLIED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other