BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 SYNCHRON® CLINICAL SYSTEM

    MDR report key: 3031787 · Received April 2, 2013

    Report

    Report Number
    2050012-2013-00177
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 6, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JGS
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    QC PRIOR TO THE EVENT WAS WITHIN LABORATORY'S ESTABLISHED RANGES. QC AFTER THE EVENT WAS OUT OF RANGE LOW. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. FSE REPLACED BOTH THE NA MEASURING AND REFERENCE ELECTRODES AND VERIFIED INSTRUMENT PERFORMANCE. THE ISSUE WAS RESOLVED. THE CAUSE OF THIS EVENT IS ATTRIBUTED TO THE NA MEASURING AND/OR REFERENCE ELECTRODE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER (BEC) TO REPORT FALSE LOW SODIUM (NA) RESULTS GENERATED BY A UNICEL DXC 600 SYNCHRON CLINICAL SYSTEM FOR 30 PATIENT SAMPLES. THE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. WHEN ROUTINE QC RECOVERED LOW, SAMPLES WERE RERUN AFTER THE SYSTEM WAS RECALIBRATED AND REPORTS WERE AMENDED. THERE WAS NO INJURY OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134225 UNICEL® DXC 600 SYNCHRON® CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER JGS BECKMAN COULTER DXC 600 NA

    Patients

    Seq Age Sex Outcome Treatment
    1