BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 1570132 · Received January 5, 2010

    Report

    Report Number
    2050012-2010-00001
    Event Type
    Malfunction
    Date Received
    January 5, 2010
    Date of Event
    December 18, 2009
    Report Date
    January 5, 2009
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJC
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC WAS ACCEPTABLE PRIOR TO THE EVENT. CUSTOMER CLEANED THE FLOW CELL WHICH RESOLVED THE PROBLEM. NO FURTHER INCIDENTS ON ERRONEOUSLY LOW NA RESULTS HAVE BEEN REPORTED TO DATE. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING ERRONEOUSLY LOW SODIUM (NA) RESULTS GENERATED BY THE UNICEL DXC 600 PRO SYNCHRON CHEMISTRY ANALYZER. THE ORIGINAL RESULTS WERE IN THE RANGE 131-135 MMOL/L AND THE REPEAT RESULTS WERE IN THE RANGE 136-139 MMOL/L. THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY 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® CHEMISTRY ANALYZER CLINICAL CHEMISTRY ANALYZER JJC BECKMAN COULTER INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1