BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2705213 · Received August 19, 2012

    Report

    Report Number
    2122870-2012-01707
    Event Type
    Malfunction
    Date Received
    August 19, 2012
    Date of Event
    July 25, 2012
    Report Date
    July 25, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JLB
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM (DXI 800) GENERATED TWO ERRONEOUS CKMB RESULTS ON TWO SEPARATE PATIENT SAMPLES. CUSTOMER REPORTED THAT THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. CUSTOMER REPORTED THAT ACCESS CKMB REAGENT, LOT 222907, AND ACCESS CKMBI CALIBRATORS, LOT 123586, WERE USED IN CONJUNCTION WITH THE DXI 800 SYSTEM. BEC FIELD SERVICE ENGINEER (FSE) REPLACED THE SAMPLE PROBE PROACTIVELY. THE FSE PERFORMED VERIFICATION TESTING WHICH PASSED WITHIN INSTRUMENT SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JLB BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1