BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEMS

    MDR report key: 1760328 · Received July 16, 2010

    Report

    Report Number
    2050012-2010-00447
    Event Type
    Malfunction
    Date Received
    July 16, 2010
    Date of Event
    June 30, 2010
    Report Date
    July 16, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLES WERE DRAWN IN BD SERUM SEPARATOR TUBES. BEFORE THE EVENT, THE ISE SYSTEM WAS CALIBRATED AND QC RESULTS WERE WITHIN THE LAB'S ESTABLISHED RANGES. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED: THE FSE REVIEWED THE DATA AND CONCLUDED THAT THE HIGH RESULTS WERE ON THE FIRST SAMPLE RUN FROM STANDBY. THE FSE REPLACED MULTIPLE HARDWARE COMPONENTS. A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING ERRONEOUSLY HIGH SODIUM (NA), POTASSIUM (K), CHLORIDE (CL), CARBON DIOXIDE (CO2), AND CALCIUM (CALC) RESULTS GENERATED BY THE UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEMS. SOME HIGH RESULTS WERE REPORTED OUT OF THE LAB. THE SPECIMENS WERE RE-TESTED AND OBTAINED RESULTS WERE LOWER FOR ALL ANALYTES. ONE PATIENT WAS TREATED WITH KAYEXALATE 30GM BASED ON A FALSE K RESULT OF 5.7MMOL/L. THERE WAS NO KNOWN HARM AS A RESULT OF THE TREATMENT AND THE PATIENT WAS DISCHARGED TO HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEMS CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXC 800 PRO

    Patients

    Seq Age Sex Outcome Treatment
    1