BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 2080916 · Received May 7, 2011

    Report

    Report Number
    2050012-2011-01439
    Event Type
    Malfunction
    Date Received
    May 7, 2011
    Date of Event
    April 7, 2011
    Report Date
    April 8, 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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER DID NOT PROVIDE INFORMATION ON SAMPLE COLLECTION AND STORAGE. QC PRIOR TO AND AFTER THE EVENT SHOWED IMPRECISION. BCI FIELD SERVICE ENGINEER (FSE) REPLACED BOTH CO2 MEASURING AND REFERENCE ELECTRODES AND VERIFIED PERFORMANCE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT THAT UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER WAS GENERATING ERRATIC CO2 RESULTS. THESE RESULTS WERE NOT REPORTED OUT OF THE LAB. SAMPLES WERE TESTED ON AN ALTERNATE INSTRUMENT AND THOSE RESULTS WERE REPORTED. THERE WAS NO AFFECT TO PATIENT.

    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