BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 800 SYNCHRON SYSTEM

    MDR report key: 2183586 · Received July 8, 2011

    Report

    Report Number
    2050012-2011-02802
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    January 20, 2010
    Report Date
    January 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
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER PERFORMED QUALITY CONTROLS AFTER THE EVENT AND DETERMINED THAT THE RESULTS WERE OUT OF SPEC. A FIELD SERVICE ENGINEER (FSE) VISITED THE FACILITY AND EXAMINED THE SYS. THE FSE REPLACED THE STIRRER MOTOR AND THE REAGENT SYRINGE. ALTHOUGH SEVERAL PARTS WERE REPLACED, A SPECIFIC ROOT CAUSE OF THIS EVENT WAS NOT DETERMINED. ACCORDINGLY, NO CONCLUSION CAN BE DRAWN. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN (B)(6), 2008 AND (B)(6), 2010 FOR ADD'L REPORTABLE EVENTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT MULTIPLE ERRONEOUSLY LOW GLUCOSE RESULTS WERE GENERATED BY THE UNICEL DXC 800 SYNCHRON SYSTEM. THE INITIAL RESULTS WERE REPORTED OUT OF THE LAB. THE CUSTOMER THEN RETESTED THE SAMPLES ON ANOTHER SYSTEM AND THE RESULTS WERE WITHIN EXPECTATION. THE AMENDED RESULTS WERE THEN REPORTED OUT OF THE LAB. IT IS NOT KNOWN IF THERE WERE ANY CHANGES TO THE PTS' CARE OR TREATMENT, HOWEVER, THERE ARE NO REPORTS OF ANY ADVERSE EVENTS OR NEED FOR MEDICAL INTERVENTION TO PREVENT OR PRECLUDE SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXC 800 SYNCHRON SYSTEM CGA BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK