BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 SYNCHRON® SYSTEM

    MDR report key: 2883599 · Received December 21, 2012

    Report

    Report Number
    2050012-2012-01927
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    November 27, 2012
    Report Date
    November 29, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JGS
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) VISITED THE SITE AND EXAMINED THE SYSTEM. THE FSE FOUND A SPLIT IN THE MODULAR CHEMISTRY SAMPLE SYRINGE AND THE MODULAR CHEMISTRY SAMPLE PROBE WAS OCCLUDED AND LEAKING. THE FSE REMOVED AND REPLACED BOTH THE SYRINGE AND THE PROBE. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER THAT FALSE LOW SODIUM (NA), POTASSIUM (K) CHLORIDE (CL), CO2 AND CALCIUM (CALC) RESULTS FOR 1 PATIENT SAMPLE WERE GENERATED BY THE UNICEL DXC 800 SYNCHRON SYSTEM. THE RESULTS WERE REPORTED OUT OF THE LAB. THE SAMPLE WAS REPEATED WITH HIGHER RESULTS WHEN THE PHYSICIAN QUESTIONED THE VALIDITY OF THE INITIAL RESULTS. QUALITY CONTROLS WERE WITHIN SPECIFICATION PRIOR TO AND AFTER THE EVENT. NO OTHER ERRONEOUS RESULTS WERE IDENTIFIED. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 800 SYNCHRON® SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JGS BECKMAN COULTER, INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR