BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC SYNCHRON ® CHEMISTRY ANALYZER

    MDR report key: 2171743 · Received July 22, 2011

    Report

    Report Number
    2050012-2011-02986
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 18, 2011
    Report Date
    June 18, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLES WERE SERUM. QC PRIOR TO THE EVENT WAS WITHIN THE LAB ESTABLISHED RANGES. AFTER THE SAMPLES WERE FLAGGED AND RERUN, QC WAS NOT RERUN. THE LAB ATTEMPTED TO RECALIBRATE THE CO2, HOWEVER, CALIBRATION FAILED. A BEC FIELD SERVICE ENGINEER (FSE) REPLACED THE CO2 MEASURING AND REFERENCE ELECTRODE. FSE VERIFIED PERFORMANCE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC (BEC) CUSTOMER IN REGARDS TO ERRONEOUS HIGH CARBON DIOXIDE (CO2) RESULTS ON 11 PATIENTS GENERATED BY THE UNICEL DXC 600I SYNCHRON CHEMISTRY. THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THE SAMPLES WERE REPEATED ON AN ALTERNATE INSTRUMENT AND LOWER RESULTS WERE OBTAINED. THE CUSTOMER PROVIDED RESULTS FROM 9 PATIENTS ONLY. PATIENT TREATMENT WAS NOT INITIATED OR WITHHELD BASED ON THE LOW RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC SYNCHRON ® CHEMISTRY ANALYZER DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER FOR CLINICAL USE. JJE BECKMAN COULTER INC. DXC 600I N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR