BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 600 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2180079 · Received July 27, 2011

    Report

    Report Number
    2122870-2011-02440
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    June 22, 2011
    Report Date
    June 22, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IMPRECISE DATA GENERATED. A DEFINITIVE ROOT CAUSE HAS NOT YET BEEN DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER, INC. (BEC) TO REPORT IMPRECISE RESULTS FOR GI MONITOR (CA 19-9 ANTIGEN) FOR TWO (2) PATIENT SAMPLES ASSAYED WITH GI MONITOR ACCESS REAGENT ON A UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM. THE IMPRECISE GI MONITOR RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THERE WAS NO IMPACT TO PATIENT TREATMENT. THE CUSTOMER REPORTED THAT THE GI MONITOR RESULTS OBTAINED FOR TWO (2) PATIENTS HAD EXCEEDED THE PRECISION CLAIMS FOR THE ASSAY. AT THE TIME OF THE EVENT, QUALITY CONTROLS WERE RECOVERING WITHIN THE LABORATORY'S ESTABLISHED RANGES. THE CUSTOMER HAD PERFORMED A FIVE (5) POINT PRECISION GI MONITOR ANALYSIS RESULTING WITH A COEFFICIENT OF VARIATION (CV) OF 3.3% WHICH FALLS WITHIN THE PRECISION CLAIMS FOR THE ASSAY. BEC OFFERED TO DISPATCH A FIELD SERVICE ENGINEER (FSE) TO THE CUSTOMER'S SITE. THE CUSTOMER DECLINED SERVICE. THE CUSTOMER ONLY WANTED THIS EVENT DOCUMENTED. A DEFINITIVE ROOT CAUSE HAS NOT YET BEEN DETERMINED FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXI 600 ACCESS® IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER, INC. DXI 600 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 GI MONITOR ACCESS REAGENT