BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® CX9 ALX CLINICAL SYSTEM

    MDR report key: 2230162 · Received September 1, 2011

    Report

    Report Number
    2050012-2011-04776
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 1, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K950958
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS GETTING CO2 CALIBRATION ERRORS AND CO2 QC LEVEL 3 WAS OUT OF SPECIFICATIONS LOW. A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE AND INSPECTED THE SYSTEM AND DID E-CAM MAINTENANCE REPLACED THE CO2 MEASURING ELECTRODE AND THEN VERIFIED PERFORMANCE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) STATING THAT THE SYNCHRON CX9 ALX CLINICAL SYSTEM GENERATED FALSE HIGH CO2 RESULTS. THE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. WHEN THE ANION GAPS FLAGGED THE SAMPLES, THEY WERE REPEATED AND THE LOWER RESULTS WERE REPORTED. THERE WAS NO AFFECT TO PATIENT WITH REGARD TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON® CX9 ALX CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. CX9 ALX NA

    Patients

    Seq Age Sex Outcome Treatment
    1