BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 1905059 · Received November 22, 2010

    Report

    Report Number
    2122870-2010-00772
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    October 26, 2010
    Report Date
    November 22, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL THE SAMPLES FROM THE PATIENT WERE DRAWN INTO SERUM SST TUBES EXCEPT FOR SAMPLE 1/5 WHICH WAS DRAWN INTO A LITHIUM HEPARIN PLASMA TUBE AND SAMPLE 1/6 WHICH WAS DRAWN INTO A PLAIN RED TOP SERUM TUBE. THE CUSTOMER NOTED ON SUPPLIED DATA THAT SAMPLE 1/4 DID HAVE FIBRIN PRESENT. QC RESULTED WITHIN SPECIFICATIONS ON THE DAYS SAMPLES FROM THE PATIENT WERE ANALYZED. A SYSTEM CHECK PERFORMED ON (B)(6) 2010 MET SPECIFICATIONS. THE CUSTOMER DID NOT QUESTION ANY OTHER RESULTS FROM OTHER PATIENT SAMPLES AND REPEAT RESULTS FROM OTHER PATIENT SAMPLES CORRELATED WELL. THE CUSTOMER SENT THREE SAMPLES FROM THE PATIENT TO CUSTOMER PRODUCT LINE SUPPORT (CPLS) FOR INVESTIGATION. THE SAMPLES WERE FIRST TESTED NEAT AND RESULTS WERE SIMILAR TO WHAT THE CUSTOMER INITIALLY OBTAINED. CPLS PERFORMED HETEROPHILE TESTING ON THE PATIENT'S SAMPLES AND NONE OF THE BLOCKERS USED HAD A SIGNIFICANT EFFECT ON THE SAMPLES. SERVICE WAS NOT 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., (BCI) REGARDING REPEATABLE ELEVATED THYROID-STIMULATING HORMONE (TSH), BLOOD-FREE THYROXINE (FT4), AND T-UPTAKE RESULTS GENERATED BY THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM FOR ONE PATIENT. THE CUSTOMER ALSO OBTAINED ERRATIC TOTAL T4 (TT4) RESULTS ON MULTIPLE SAMPLES FROM THE SAME PATIENT. THE RESULTS WERE REPORTED OUT OF THE LAB. THE CUSTOMER DID NOT REPORT EFFECT 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 44 YR