BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEMS

    MDR report key: 1598168 · Received February 11, 2010

    Report

    Report Number
    2050012-2010-00047
    Event Type
    Malfunction
    Date Received
    February 11, 2010
    Date of Event
    January 25, 2010
    Report Date
    February 11, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JGS
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ISE SYSTEM WAS CALIBRATED AND QC RESULTS WERE WITHIN THE LAB'S ESTABLISHED RANGES. CUSTOMER USED THE TWICE-WEEKLY FLOW CELL MAINTENANCE PROCEDURE. THE BCI ENGINEER CULTURED THE ISE SYSTEM. THE CULTURE WAS NEGATIVE. HOTLINE AND THE BCI ENGINEER ADVISED THE CUSTOMER ON HOW TO IMPROVE ISE PERFORMANCE. 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 LOW SODIUM (NA) RESULTS GENERATED BY THE UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEMS. THE INITIAL RESULTS IN THE RANGE OF 131-157 MMOL/L WERE REPORTED OUT OF THE LAB. THE ORIGINAL SPECIMENS WERE RE-TESTED ON A DIFFERENT INSTRUMENT AND HIGHER NA RESULTS WERE OBTAINED. 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