BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 1065951 · Received June 25, 2008

    Report

    Report Number
    2122870-2008-00202
    Event Type
    Other
    Date Received
    June 25, 2008
    Date of Event
    May 30, 2008
    Report Date
    June 25, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLES WERE PLASMA COLLECTED IN PLASTIC TUBE. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S LAB: FSE FOUND ASPIRATE PROBE 3 LEAKING AIR AT THE MANIFOLD FITTING. FSE BYPASSED QUICK DISCONNECT FITTING, ORDERED NEW MANIFOLD AND RAN SYSTEM CHECK WHICH PASSED. THE FSE REPLACED BULK HEAD FITTINGS AND ASPIRATE PERIPUMP. PERFORMED SYSTEM CHECK AGAIN, WHICH PASSED. VERIFIED REPAIR PER ESTABLISHED PROCEDURES. RESULTS MEET PUBLISHED PERFORMANCE SPECS. UPON F/U WITH CUSTOMER, THE CUSTOMER INDICATES THAT THEY DID GO BACK AND RE-TEST PT SAMPLES. 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 PT. CUSTOMER TESTED A PT SAMPLE FOR ACCU TNI AND OBTAINED A RESULT OF 0.53NG/ML AND IT REPEATED AT 0.20NG/ML. IT IS UNCLEAR WHETHER THE ERRONEOUS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. TO DATE, THE CUSTOMER HAS NOT REPORTED ANY DEATH, INJURY, OR CHANGE TO PT TREATMENT AS A RESULT OF 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