BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEMS

    MDR report key: 1675086 · Received May 5, 2010

    Report

    Report Number
    2050012-2010-00242
    Event Type
    Malfunction
    Date Received
    May 5, 2010
    Date of Event
    April 21, 2010
    Report Date
    May 5, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM IS ROUTINELY CALIBRATED EVERY 8 HOURS FOLLOWED BY QC SAMPLES. PATIENT INTERNAL CONTROL SAMPLES ARE RUN EVERY 4 HOURS. PRIOR TO EACH EVENT QC SAMPLES WERE WITHIN THE LAB'S ESTABLISHED RANGES. THE SHIFT HIGH WAS DETECTED ON A PATIENT INTERNAL CONTROL SAMPLE. OVER A PERIOD OF TWO DAYS THERE WERE OCCASIONAL SHIFTS HIGH OF 10-15 MMOL/L ON NA AND CL RESULTS. A FIELD SERVICE ENGINEER (FSE) REPLACED THE FLOW CELL AFTER FINDING A CRACK AND REPLACED THE EIC. THIS APPEARS TO HAVE RESOLVED THE ISSUE. 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) AND CHLORIDE (CL) RESULTS GENERATED BY THE UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEMS. THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LAB. UPON REPEAT LOWER RESULTS WERE OBTAINED AND AMENDED REPORTS WERE ISSUED. THE CUSTOMER HAS NOT RECEIVED ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED TO OR CONNECTED WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1