BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEMS

    MDR report key: 1667225 · Received April 26, 2010

    Report

    Report Number
    2050012-2010-00220
    Event Type
    Malfunction
    Date Received
    April 26, 2010
    Date of Event
    April 5, 2010
    Report Date
    April 26, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JGS
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM IS ROUTINELY CALIBRATED EVERY 24 HOURS AND QC SAMPLES ARE RUN EVERY 8 HOURS. PRIOR TO THE EVENT, QC RESULTS WERE WITHIN THE LAB'S ESTABLISHED RANGES. A FIELD SERVICE ENGINEER (FSE) REPLACED THE FLOW CELL. 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 ERRONEOUSLY HIGH SODIUM (NA) RESULTS GENERATED BY THE UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEMS. UPON REPEAT LOWER RESULTS WERE OBTAINED. THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LAB. 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 800 PRO SYNCHRON® CLINICAL SYSTEMS CLINICAL CHEMISTRY ANALYZER JGS BECKMAN COULTER INC. DXC 800 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1