BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 2891441 · Received December 31, 2012

    Report

    Report Number
    2050012-2012-01983
    Event Type
    Malfunction
    Date Received
    December 31, 2012
    Date of Event
    December 6, 2012
    Report Date
    December 6, 2012
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JGS
    PMA / PMN Number
    K042291
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    QC PRIOR TO AND AFTER THE EVENT WAS WITHIN LAB-ESTABLISHED RANGES. A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND REPLACED THE SODIUM (NA) ELECTRODE AND CARBON BRIDGE, WHICH RESOLVED THE ISSUE. INSTRUMENT PERFORMANCE WAS VERIFIED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) IN REGARDS TO OBTAINING FALSE LOW SODIUM (NA) RESULTS FOR SIX (6) PATIENT SAMPLES GENERATED ON THE UNICEL DXC 600 PRO SYNCHRON CHEMISTRY ANALYZER. THE FALSE RESULTS WERE REPORTED OUT OF THE LABORATORY. WHEN THE ISSUE WAS DISCOVERED, THE SAMPLES WERE RERUN ON ANOTHER INSTRUMENT IN THE LABORATORY AND REPORTS WERE AMENDED. THE RESULTS PROVIDED BY THE CUSTOMER ARE SHOWN IN THIS REPORT. THERE WAS NO IMPACT TO PATIENT OR PATIENT TREATMENT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JGS BECKMAN COULTER INC. DXC 600 PRO N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR