BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600 SYNCHRON SYSTEM

    MDR report key: 2172277 · Received June 24, 2011

    Report

    Report Number
    2050012-2011-02568
    Event Type
    Malfunction
    Date Received
    June 24, 2011
    Date of Event
    April 20, 2010
    Report Date
    April 20, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    CGA
    PMA / PMN Number
    K042291
    Removal / Correction Number
    Z-2388-2010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SERVICE OR EXAMINATION OF THE SYSTEM WAS CONDUCTED BY THE MANUFACTURER. THE CUSTOMER REPORTS REVIEWING THE SAMPLE AND DETERMINED THAT THE USE OF A SHORT SAMPLE WAS THE CAUSE OF THE EVENT. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN JANUARY 1, 2008 AND OCTOBER 23, 2010 FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT AN ERRONEOUSLY LOW GLUCOSE RESULT WAS GENERATED BY THE UNICEL DXC 600 SYNCHRON SYSTEM. THE RESULT WAS REPORTED OUT OF THE LABORATORY AND THE VALIDITY OF THE REPORTED RESULT WAS QUESTIONED. THE RESULT DID NOT MATCH THE RESULT FROM A POINT OF CARE DEVICE. THE SAMPLE WAS MANUALLY REDISPENSED AND RE-TESTED; THE RETURNED A RESULT WITHIN EXPECTATIONS. THE RETEST RESULT WAS AMENDED AND REPORTED OUT OF THE LABORATORY. QUALITY CONTROL RESULTS WERE WITHIN SPECIFICATION PRIOR TO AND AFTER THE EVENT. THE CUSTOMER INDICATED THAT THE INITIAL RESULT WAS FROM A SHORT SAMPLE ATOP RED CELLS WITH NO GEL SEPARATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXC 600 SYNCHRON SYSTEM CGA BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK LX GLUCOSE 2X2L