BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600 SYNCHRON SYSTEM

    MDR report key: 2172301 · Received June 24, 2011

    Report

    Report Number
    2050012-2011-02478
    Event Type
    Malfunction
    Date Received
    June 24, 2011
    Date of Event
    March 16, 2010
    Report Date
    March 16, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SERVICE OR EXAMINATION OF THE SYSTEM WAS PERFORMED. CUSTOMER SUPPORT REPRESENTATIVE ADVISED THE CUSTOMER TO PRIME THE REAGENT STRAW WITH WARM DISTILLED WATER. THE CUSTOMER THEN PERFORMED UNSPECIFIED MAINTENANCE AND CALIBRATION. THE CUSTOMER THEN RAN PRECISION TESTS AND THE RESULTS WERE WITHIN EXPECTATION. THE SPECIFIC ROOT CAUSE OF THIS EVENT COULD NOT BE DETERMINED. THIS IS ONE OF EIGHT (8) MEDWATCH REPORTS BEING SUBMITTED FOR THIS SINGLE MALFUNCTION AS 8 SEPARATE PATIENT RESULTS WERE AFFECTED. REFERENCE THE BELOW MDR NUMBERS FOR ALL ASSOCIATED EVENTS: 2050012-2010-00159, 02472, 02473, 02474, 02475, 02476, 02477. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN (B)(4) 2008 AND (B)(4) 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 DISSEMINATED FROM THE LABORATORY AND THE RESULT VALIDITY WAS QUESTIONED BY THE PRACTITIONER. THE CUSTOMER THEN RE-TESTED THE SAMPLE AND SUBMITTED AN AMENDED RESULT. IT IS NOT KNOWN IF THERE WAS ANY CHANGE TO THE PATIENTS' CARE OR TREATMENT, HOWEVER, THERE IS NO INDICATION OF ANY ADVERSE EVENT OR NEED FOR MEDICAL INTERVENTION TO PREVENT OR PRECLUDE AN ADVERSE EVENT.

    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 70 YR