BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEMS

    MDR report key: 1676030 · Received May 6, 2010

    Report

    Report Number
    2050012-2010-00244
    Event Type
    Malfunction
    Date Received
    May 6, 2010
    Date of Event
    April 7, 2010
    Report Date
    May 6, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CALIBRATION IS ROUTINELY RUN EVERY 24 HOURS AND QC SAMPLES ARE RUN EVERY 8 HOURS. BEFORE AND AFTER THE EVENT, K QC RESULTS WERE WITHIN THE LAB'S ESTABLISHED RANGES. BCI WAS NOT CONTACTED WITH THIS 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 LOW POTASSIUM (K) RESULT GENERATED BY THE UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEMS FOR ONE PATIENT. THE ORIGINAL RESULT OBTAINED WAS 2.8 MMOL/L. THE ERRONEOUS RESULT WAS REPORTED OUTSIDE OF THE LAB. THE PATHOLOGIST REVIEWED THE RESULT THE FOLLOWING DAY AND REQUESTED THE SAMPLE BE REPEATED. THE RESULT OBTAINED WAS 3.2 MMOL/L. AN AMENDED REPORT WAS ISSUED. THE PATIENT WAS TREATED WITH IV POTASSIUM. IT IS NOT KNOWN IF THERE WAS ANY SERIOUS HARM TO THE PATIENT AS A RESULT OF THE TREATMENT.

    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 62 YR