BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 1952995 · Received January 7, 2011

    Report

    Report Number
    2122870-2011-00007
    Event Type
    Injury
    Date Received
    January 7, 2011
    Date of Event
    November 22, 2010
    Report Date
    December 9, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JLW
    PMA / PMN Number
    K023764
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE WAS NOT AVAILABLE FOR TESTING BY CUSTOMER PRODUCT LINE SUPPORT (CPLS). PER CUSTOMER, QC WAS RECOVERING WITHIN ESTABLISHED RANGES. AT THE TIME OF EVENT, SERVICE WAS NOT DISPATCHED. THE CUSTOMER WAS NOT QUESTIONING INSTRUMENT PERFORMANCE. ALTHOUGH A PATIENT SOURCE INTERFERENT IS CONSIDERED THE LIKELY ROOT CAUSE, NO CLEAR ROOT CAUSE FOR THIS EVENT HAS BEEN DETERMINED TO DATE.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER INC., (BCI) REPRESENTATIVE THAT A PATIENT THYROID-STIMULATING HORMONE (TSH) RESULT GENERATED ON UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM WAS ELEVATED, RECOVERING ABOVE THE NORMAL REFERENCE RANGE. THE TSH RESULT WAS REPORTED OUT OF THE LAB AND WAS QUESTIONED BY THE PHYSICIAN AS NOT MATCHING THE PATIENT'S CLINICAL PRESENTATION. ANOTHER TSH RESULT, OBTAINED BY A DIFFERENT METHODOLOGY, WAS IN THE NORMAL REFERENCE RANGE. CORRECTED REPORT WAS ISSUED. PER CUSTOMER, THE PATIENT WAS TREATED WITH SYNTHROID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JLW BECKMAN COULTER INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other