BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 1810391 · Received August 20, 2010

    Report

    Report Number
    2122870-2010-00468
    Event Type
    Malfunction
    Date Received
    August 20, 2010
    Date of Event
    July 23, 2010
    Report Date
    August 20, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    MMI
    PMA / PMN Number
    K023764
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS SENT TO CUSTOMER PRODUCT LINE SUPPORT (CPLS) EAST FOR ADDITIONAL TESTING. CPLS PERFORMED DILUTION AND HETEROPHILE TESTING; HOWEVER, CPLS DID NOT DETECT INTERFERENCE. SERVICE WAS NOT DISPATCHED. A CLEAR ROOT CAUSE CAN NOT BE DETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO AN ACCUTNI RESULT IN THE RISK STRATIFICATION RANGE GENERATED BY THE UNICEL (R) DXI 800 ACCESS CHEMISTRY ANALYZER THE ERRONEOUS RESULT WAS REPORTED OUT OF THE LABORATORY. PATIENT SAMPLE WAS REPEATED ON THE SAME UNIT AND PRODUCED THE SAME RESULT. THE SAMPLE WAS ANALYZED ON AN ALTERNATE METHODOLOGY AND IT PRODUCED ELEVATED RESULT AS WELL. THE PATIENT WAS SENT TO ANOTHER FACILITY AND HAD A TROPONIN T TEST PERFORMED AND THE RESULT WAS NEGATIVE.

    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. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1