BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600 SYNCHRON SYSTEM

    MDR report key: 2180963 · Received July 1, 2011

    Report

    Report Number
    2050012-2011-02781
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    September 11, 2009
    Report Date
    September 11, 2009
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    Z-2388-2010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SERVICE OF THE SYSTEM WAS CONDUCTED BY THE MFR. THE CUSTOMER PROVIDED DATA RELATIVE TO THE EVENT. THE DATA WAS REVIEWED AND IT WAS DETERMINED THAT THE SAMPLE VOLUME WAS SMALL AT THE TIME OF COLLECTION. BASED UPON ALL AVAILABLE INFO, THE ROOT CAUSE APPEARS TO BE BUBBLES ON THE TOP OF THE SAMPLE CUP. ACCORDINGLY, USER ERROR DURING SAMPLE PROCESSING CONTRIBUTING TO THIS EVENT. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN JANUARY 1, 2008 AND OCTOBER 23, 2010 FOR ADD'L 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 ORIGINAL SAMPLE WAS DESCRIBED AS A BLOODY SPINAL TAP. THE SAMPLE WAS TRANSFERRED FROM ITS COLLECTION CONTAINER TO A SAMPLE CONTAINER; THE LAB INDICATED THE POSSIBILITY OF BUBBLES REMAINING ON THE SURFACE OF THE SAMPLE CUP. THE RESULT WAS REPORTED OUT OF THE LABORATORY AND THE VALIDITY WAS QUESTIONED BY THE PRACTITIONER. THE SAMPLE WAS RETESTED AND YIELDED A RESULT WITHIN EXPECTATIONS BASED ON THE PT'S CLINICAL PICTURE. THE RETEST RESULT WAS AMENDED AND REPORTED OUT. THERE WAS NO CHANGE TO THE PT'S CARE OR TREATMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK