BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2143679 · Received June 29, 2011

    Report

    Report Number
    2050012-2011-02763
    Event Type
    Malfunction
    Date Received
    June 29, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 2, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC PRIOR TO AND AFTER THE EVENT WAS WITHIN THE LAB'S ESTABLISHED RANGES. A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE AND FOUND LEAKING LINES ON THE FLOWCELL. THE FSE CLEANED UP THE LEAK, REPLACED LINES AND VERIFIED PERFORMANCE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THE UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEM GENERATED LOW ANION GAPS. NO RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER PROVIDED 7 PATIENT PRINTOUTS. OF THOSE SAMPLES, ONLY 1 SAMPLE SHOWED A DIFFERENCE IN CO2 RECOVERY THAT EXCEEDED ASSAY PRECISION CLAIMS. ANY DIFFERENCES IN NA, CL OR CO2 FOR OTHER SAMPLES WERE WITHIN THE PRECISION OF THE ASSAY. THERE WAS NO AFFECT TO PATIENT WITH REGARD TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1