BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2122325 · Received June 13, 2011

    Report

    Report Number
    2122870-2011-01846
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    February 11, 2011
    Report Date
    May 17, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER IS INSTRUCTED, PER OPERATOR'S MANUAL, TO REVIEW QC CHARTS AND GRAPHS FOLLOWING RECEIVING QC RESULTS. THE RED TILE IS ONLY A VISUAL REMINDER OF THE FAILURE AND GOOD LABORATORY PRACTICES WOULD DICTATE THE CUSTOMER PERSONALLY REVIEW THE DATA. CUSTOMER PRODUCT LINE SUPPORT (CPLS) IS CURRENTLY LOOKING INTO POTENTIAL SOFTWARE IMPROVEMENTS. SERVICE WAS NOT DISPATCHED FOR THIS EVENT AS CUSTOMER IS NOT QUESTIONING INSTRUMENT PERFORMANCE. SOFTWARE HAS BEEN DETERMINED TO BE THE ROOT CAUSE OF THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI), REPORTING THAT THE SOFTWARE WAS NOT TURNING THE QC TILE RED DURING QC FAILURES WHEN THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM PRODUCED AN OUT OF RANGE RESULT OF >78NG/ML. NO ERRONEOUS RESULTS WERE REPORTED BY THE CUSTOMER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1