BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2223790 · Received August 26, 2011

    Report

    Report Number
    2122870-2011-02875
    Event Type
    Malfunction
    Date Received
    August 26, 2011
    Date of Event
    July 24, 2011
    Report Date
    July 26, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS DRAWN INTO A LITHIUM HEPARIN PLASMA TUBE. THE SPECIMEN WAS SAMPLED FROM THE PRIMARY TUBE AND THE DXI IS ON AN AUTOMATION LINE. NO SPECIFIC CENTRIFUGATION DETAILS WERE SUPPLIED. PER THE CUSTOMER COMPLAINT RECORD, THE SYSTEM WAS CURRENTLY PERFORMING WITHIN QC SPECIFICATIONS UPON THE TIME OF THE COMPLAINT SUBMISSION. ACTUAL QC DATA WAS NOT SUPPLIED. THERE WAS NO INDICATION THAT SERVICE WAS DISPATCHED FOR THIS EVENT. A ROOT CAUSE FOR THIS EVENT WAS NOT DETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) IN REGARDS TO OBTAINING AN ERRONEOUSLY HIGH THYROID STIMULATING HORMONE (TSH) RESULT ABOVE THE NORMAL REFERENCE RANGE FOR ONE PATIENT THAT WAS GENERATED BY THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. THE ERRONEOUS RESULT WAS REPORTED OUT OF THE LABORATORY; HOWEVER, UPON REPEAT ANALYSIS THE RESULT YIELDED WITHIN THE NORMAL REFERENCE RANGE AND AN AMENDED REPORT WAS ISSUED. THE CUSTOMER REPORTED NO DEATH OR INJURY ASSOCIATED TO THIS EVENT. CHANGE TO PATIENT TREATMENT IS UNKNOWN TO DATE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1