BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 800 SYNCHRON SYSTEM

    MDR report key: 2180959 · Received July 1, 2011

    Report

    Report Number
    2050012-2011-02778
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    December 5, 2009
    Report Date
    December 8, 2009
    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
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) VISITED THE FACILITY AND EXAMINED THE SYSTEM. THE FSE REPLACED THE PROBE ASSEMBLY. THE FSE ALSO PERFORMED A STIRRER MOTOR UPDATE THAT WAS PREVIOUSLY SCHEDULED PRIOR TO THE EVENT. ALTHOUGH SEVERAL PARTS WERE REPLACED, A SPECIFIC ROOT CAUSE WAS NOT DETERMINED; ACCORDINGLY, NO CONCLUSION CAN BE DRAWN. THIS IS ONE OF TWO MEDWATCH REPORTS BEING SUBMITTED AS THE CUSTOMER REPORTED EVENTS OCCURRING ON TWO SEPARATE DAYS. SEE THE MDR NUMBER BELOW FOR ASSOCIATED REPORT. MDR# 2050012-2011-02779. 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

    INTERNATIONAL CUSTOMER REPORTED THAT ERRONEOUSLY LOW GLUCOSE RESULTS WERE GENERATED BY THE UNICEL DXC 800 SYNCHRON SYSTEM. THE RESULTS WERE NOT REPORTED OUT OF THE LAB. NO SAMPLE VOLUME ERRORS WERE OBSERVED DURING PROCESSING. A RETEST OF THE ORIGINAL SAMPLES YIELDED HIGHER RESULTS AND WERE REPORTED. THE LAB CONTINUED TO PROCESS SAMPLES. QUALITY CONTROLS WERE WITHIN SPEC PRIOR TO, IN BETWEEN AND AFTER THE EVENTS. THERE WAS NO CHANGE TO THE PTS' CARE OR TREATMENT RELATED TO THIS EVENT.

    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