BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER.

    MDR report key: 1973429 · Received January 30, 2011

    Report

    Report Number
    2050012-2011-00289
    Event Type
    Malfunction
    Date Received
    January 30, 2011
    Date of Event
    December 31, 2010
    Report Date
    December 31, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT REPORT ANY ISSUES WITH QC OR CALIBRATION. NO OTHER ANALYTES ARE AFFECTED. HOTLINE INSTRUCTED THE CUSTOMER TO PERFORM MONTHLY GLUCOSE CUP CLEANING MAINTENANCE AND REPLACED THE GLUCOSE CUP STIR BAR. PER CUSTOMER, MAINTENANCE WAS PERFORMED WITHIN SCHEDULED DATES. NO RECORDS WERE PROVIDED. AS OF (B)(4) 2011, THE CUSTOMER HAD NOT REPORTED ANY ADDITIONAL DUPLICATES OUTSIDE THE 10% CRITERIA. A CLEAR ROOT CAUSE CAN NOT BE DETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT INTERMITTENT DIFFERENCE IN GLUCOSE MODULAR (GLUM) DUPLICATE RESULTS GENERATED ON THE UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER UNITS. THE CUSTOMER RUNS GLUM PATIENTS IN DUPLICATE AND THE RESULTS ARE NOT MATCHING WITHIN A CUSTOMER ESTABLISHED CRITERIA OF 10%. PATIENT RESULTS ARE NOT AVAILABLE. THE RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. PATIENT TREATMENT WAS NOT IMPACTED BY THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER. CLINICAL CHEMISTRY ANALYZER, JJE BECKMAN COULTER INC. DXC800 PRO N/A

    Patients

    Seq Age Sex Outcome Treatment
    1