BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 1200167 · Received October 1, 2008

    Report

    Report Number
    2122870-2008-00309
    Event Type
    Other
    Date Received
    October 1, 2008
    Date of Event
    September 9, 2008
    Report Date
    October 1, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE IN QUESTION WAS LITHIUM HEPARIN PLASMA AND DID NOT VISUALLY APPEAR HEMOLYZED, LIPEMIC OR ICTERIC. THE SAMPLE WAS PROCESSED VIA THE AUTOMATION LINE. QC WAS IN RANGE PRIOR TO AND FOLLOWING THE EVENT. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND ON SITE IN 2008: FSE CONFIRMED ISSUE WAS ISOLATED TO THE ONE PATIENT'S SAMPLE. FSE OBSERVED NO ISSUES VISUALLY WITH THE SYSTEM. FSE PERFORMED A SYSTEM CHECK AND A PRECISION RUN. ALL TEST RESULTS WERE ACCEPTABLE. FSE VERIFIED REPAIR PER ESTABLISHED PROCEDURES AND RESULTS MET PUBLISHED PERFORMANCE SPECIFICATIONS. A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE, A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING AN ERRONEOUSLY ELEVATED ACCU TNI RESULT GENERATED BY THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM FOR ONE PATIENT. A PATIENT SAMPLE, WHEN TESTED FOR ACCU TNI, GAVE A RESULT OF 3.84NG/ML. UPON REPEAT, IT GAVE RESULTS OF 0.18 AND 0.09NG/ML. THE ERRONEOUS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER INDICATED AN ECHOCARDIOGRAM WAS ORDERED AS A RESULT OF THE ERRONEOUSLY ELEVATED RESULTS. HOWEVER, REPORT OF ACTUAL CHANGE TO TREATMENT, DEATH, OR INJURY WAS NOT REPORTED IN CONJUNCTION WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA