BEUDAMED
    FDA Adverse Event Summary report: N

    SYNCHRON UNICEL DXC 600

    MDR report key: 2003403 · Received March 1, 2011

    Report

    Report Number
    2050012-2011-00505
    Date Received
    March 1, 2011
    Date of Event
    January 28, 2011
    Report Date
    January 28, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC WAS WITHIN LABORATORY ESTABLISHED RANGES PRIOR TO THE EVENT. QC RUN IN THE AFTERNOON WAS OUT OF RANGE LOW. QC WAS RERUN AT 1734 WAS WITHIN RANGE. THE CUSTOMER REPLACED THE K TIP WHICH RESOLVED THE ISSUE. SERVICE WAS NOT DISPATCHED; HOWEVER, SERVICE ASSISTED AND INSTRUCTED THE CUSTOMER VIA TELEPHONE TO RUN ADDITIONAL SAMPLES TO STABILIZE THE NEW ELECTRODE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT AN ERRONEOUS POTASSIUM (K) RESULT GENERATED BY THE SYNCHRON UNICEL DXC 600 CLINICAL CHEMISTRY ANALYZER. THE RESULTS WERE REPORTED OUT OF THE LABORATORY. THE SAMPLE WAS RERUN AFTER TROUBLESHOOTING CORRECTED THE ISSUE AND HIGHER RESULT WAS OBTAINED AND REPORTED. PATIENT TREATMENT WAS NOT INITIATED OR WITHHELD DUE TO THE LOW RESULT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON UNICEL DXC 600 CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXC600 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1