BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER.

    MDR report key: 2120816 · Received June 11, 2011

    Report

    Report Number
    2050012-2011-02116
    Event Type
    Malfunction
    Date Received
    June 11, 2011
    Date of Event
    May 3, 2011
    Report Date
    May 3, 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS SERUM. THE CUSTOMER CALIBRATES EVERY 24 HOURS AND RUNS QC EVERY SHIFT. CALIBRATION AND QC INFORMATION WAS REQUESTED BUT NOT PROVIDED. A BCI SERVICE DECONTAMINATED THE SYSTEM AND REPLACED THE CARBON BRIDGE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO THE INSTRUMENT UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER GENERATED LOW ANION GAPS, WHICH WERE CAUSED BY LOW NA AND HIGH CL. THE RESULTS WERE NOT REPORTED OUT OF THE LABORATORY; HENCE PATIENT TREATMENT WAS NOT IMPACTED BY THIS EVENT. THE SAMPLES WERE REPEATED AND WERE REPORTED OUT OF THE LABORATORY. THE CUSTOMER PROVIDED RESULTS FROM 1 PATIENT. QA NOTED THAT THE DIFFERENCE IN NA AND K RESULTS EXCEEDED ASSAY PRECISION CLAIMS, BUT THE DIFFERENCES IN CL RESULTS WAS WITHIN CLAIMS.

    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