BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 800 SYNCHRON SYSTEM

    MDR report key: 2180956 · Received July 1, 2011

    Report

    Report Number
    2050012-2011-02768
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    January 6, 2010
    Report Date
    January 6, 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

    THE FIELD SERVICE ENGINEER (FSE) VISITED THE FACILITY AND EXAMINED THE SYSTEM. THE FSE REPLACED THE GLUCOSE MODULE ASSEMBLY. ALTHOUGH PARTS WERE REPLACED, THE SPECIFIC ROOT CAUSE OF THIS SINGLE EVENT REMAINS UNK; ACCORDINGLY, NO CONCLUSION CAN BE DRAWN. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN (B)(4) 2008 AND (B)(4) 2010 FOR ADD'L REPORTABLE EVENTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A LOW GLUCOSE RESULT WAS GENERATED BY THE UNICEL DXC 800 SYNCHRON SYSTEM FOR ONE PT. THE SYSTEM GENERATED CRITICAL RERUN FEATURE WAS TRIGGERED AND RETURNED A RESULT WITHIN EXPECTATION. QUALITY CONTROLS WERE WITHIN ACCEPTABLE RANGE PRIOR TO AND AFTER THE EVENT. THE INITIAL LOW RESULT WAS NOT REPORTED OUT OF THE LAB. THE SAMPLE WAS RETESTED ON THE SAME SYSTEM AND YIELDED AN ACCEPTABLE RESULT. THERE WAS NO CHANGE TO THE PTS' CARE OR TREATMENT.

    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 74 YR