BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER.

    MDR report key: 2120811 · Received June 10, 2011

    Report

    Report Number
    2050012-2011-02045
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Date of Event
    April 21, 2011
    Report Date
    April 26, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS SERUM. QC AND CALIBRATION WERE WITHIN RANGE PRIOR TO OR AFTER THE EVENT. SERVICE WAS NOT DISPATCHED FOR THIS PARTICULAR EVENT, HOWEVER SERVICE HAS VISITED THIS ACCOUNT MANY TIMES OVER THE PAST FEW MONTHS AND LOCAL ALONG WITH NATIONAL FIELD SERVICE CONTINUES TO MONITOR THIS ACCOUNT. NO DEFINITIVE ROOT CAUSE CAN BE DETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT ERRONEOUS HIGH GLUCOSE MODULAR (GLUM) SERUM RESULT DID NOT MATCH THE DUPLICATE RESULT GENERATED ON THE UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER. THE CUSTOMER RUNS GLUM PATIENTS IN DUPLICATE MODE. THE INITIAL RESULT WAS 98 MG/DL AND THE DUPLICATE WAS 112 MG/DL. THE SAMPLE WAS REPEATED ON ANOTHER INSTRUMENT AND THE OBTAINED RESULTS (99, 99, AND 98 MG/DL) WERE SIMILAR TO THE INITIAL RUN. THE REPEAT RESULTS WERE REPORTED. THE RESULT WAS 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