BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 2060445 · Received April 17, 2011

    Report

    Report Number
    2050012-2011-01171
    Event Type
    Malfunction
    Date Received
    April 17, 2011
    Date of Event
    March 18, 2011
    Report Date
    March 18, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PROBLEMS NOTED WITH CALIBRATION OR QC. GLUCOSE ELECTRODE WAS PREVIOUSLY REPLACED ON (B)(4) 2011. BCI FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED FOR THIS EVENT. FSE REPLACED GLUCOSE ELECTRODE AGAIN AND RAN NUMEROUS CALIBRATION AND CONTROLS. PRECISION WAS WITHIN SPECIFICATIONS. ALTHOUGH GLUCOSE ELECTRODE WAS REPLACED, THE ROOT CAUSE IS UNKNOWN AT THIS TIME.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT ONE (1) FALSE HIGH GLUCM RESULT NOTED WHEN RUN IN DUPLICATE MODE ON THE UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER. SAMPLE WAS RERUN ON ALTERNATE INSTRUMENT IN DUPLICATE MODE. THIS RESULT WAS REPORTED OUT OF THE LAB. NO REPORT OF DEATH OR INJURY HAVE BEEN REPORTED IN CONNECTION WITH 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. DXC 800 PRO N/A

    Patients

    Seq Age Sex Outcome Treatment
    1