BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEMS

    MDR report key: 1657081 · Received April 13, 2010

    Report

    Report Number
    2050012-2010-00172
    Event Type
    Malfunction
    Date Received
    April 13, 2010
    Date of Event
    March 17, 2010
    Report Date
    April 12, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JGS
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM IS CALIBRATED AND QC SAMPLES ARE RUN UPON STARTUP EACH MORNING. SERVICE ENGINEER (FSE) WAS DISPATCHED: THE FSE CLEANED THE CL PORT AND THE FLOW CELL. THE FSE REPLACED PARTS. THE FSE OBSERVED THAT ONE SAMPLE THAT GENERATED HIGH RESULTS HAD VISIBLE GEL IN THE SAMPLE. 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 INTERMITTENTLY, ERRONEOUSLY HIGH SODIUM (NA) AND CHLORIDE (CL) RESULTS GENERATED BY THE UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEMS. THE RESULTS WERE REPORTED OUT OF THE LAB. THE ORIGINAL SAMPLES WERE RETESTED AND RESULTS WERE AMENDED. 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 JGS BECKMAN COULTER INC. DXC 600 PRO

    Patients

    Seq Age Sex Outcome Treatment
    1