BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 1992223 · Received February 15, 2011

    Report

    Report Number
    2122870-2011-00390
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    January 7, 2011
    Report Date
    January 18, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER SENT SAMPLE TO CUSTOMER PRODUCT LINE SUPPORT (CPLS) FOR ADDITIONAL TESTING. CPLS WAS ABLE TO DETECT A PATIENT SOURCE INTERFERENCE. A PATIENT SOURCE INTERFERENT IS THE ROOT CAUSE OF THIS EVENT. SERVICE WAS NOT DISPATCHED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) REGARDING A HIGHER THAN EXPECTED THYROID-STIMULATING HORMONE (TSH) RESULT GENERATED BY THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM FOR ONE PATIENT. SUBSEQUENT TESTING ON AN ALTERNATE METHODOLOGY PRODUCED A LOWER RESULT THAT BETTER MATCHED THE PATIENT'S CLINICAL PRESENTATION. THE RESULT WAS REPORTED OUT OF THE LAB. IT IS UNKNOWN IF PATIENT TREATMENT WAS AFFECTED.

    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. NA

    Patients

    Seq Age Sex Outcome Treatment
    1