BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 1766530 · Received July 22, 2010

    Report

    Report Number
    2122870-2010-00353
    Event Type
    Malfunction
    Date Received
    July 22, 2010
    Date of Event
    May 25, 2010
    Report Date
    July 21, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC WAS WITHIN SPECIFICATIONS PRIOR TO THE EVENT. THE CUSTOMER SENT SAMPLE TO CUSTOMER PRODUCT LINE SUPPORT (CPLS) FOR ADDITIONAL TESTING. CPLS TESTING CONFIRMS ROOT CAUSE TO BE BIOTIN INTERFERENCE (PATIENT SOURCE INTERFERENCE) IN THE TT3 ASSAY. SERVICE WAS NOT DISPATCHED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) REGARDING ABOVE THE NORMAL REFERENCE RANGE RESULTS FOR TOTAL TRIIODOTHYRONINE (TT3) AND THYROID-STIMULATING HORMONE (TSH) GENERATED BY THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM FOR ONE PATIENT. SUBSEQUENT TESTING ON AN ALTERNATE METHODOLOGY PRODUCED LOWER RESULTS FOR BOTH ANALYTES. THE CUSTOMER DID NOT REPORT AFFECT TO THE PATIENT OR USER ATTRIBUTED OR CONNECTED TO THIS EVENT.

    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