BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEMS

    MDR report key: 1597309 · Received February 9, 2010

    Report

    Report Number
    2050012-2010-00049
    Event Type
    Malfunction
    Date Received
    February 9, 2010
    Date of Event
    January 15, 2010
    Report Date
    February 9, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JGS
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC WAS WITHIN THE 2SD LIMITS, HOWEVER, THE RESULTS AT TIMES WERE BIASED TOWARDS THE LOWER END OF THE RANGE. CUSTOMER REPLACED THE SODIUM REFERENCE ELECTRODE, PERFORMED TWICE-WEEKLY MAINTENANCE, CALIBRATED THE INSTRUMENT AND RAN QC. A FEW DAYS LATER THE CUSTOMER CALLED BCI AND REQUESTED A SERVICE VISIT. FIELD SERVICE ENGINEER (FSE) PERFORMED A PREVENTIVE MAINTENANCE (PM). A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING LOW SODIUM (NA) RESULTS GENERATED BY THE UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEMS FOR MULTIPLE PATIENTS. THE INITIAL RESULTS IN THE RANGE OF 125-142 MMOL/L WERE REPORTED OUT OF THE LAB AND SOME OF THE LOW RESULTS WERE QUESTIONED BY THE PHYSICIAN. THE SPECIMENS WERE RE-TESTED AND HIGHER NA RESULTS WERE OBTAINED. CUSTOMER STATED THAT THEY DID NOT BELIEVE THAT PATIENT CARE WAS IMPACTED, AS SOME OF THE PATIENT RESULTS WERE QUESTIONED BY A PHYSICIAN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1