BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600 SYNCHRON SYSTEM

    MDR report key: 2172280 · Received June 24, 2011

    Report

    Report Number
    2050012-2011-02430
    Event Type
    Malfunction
    Date Received
    June 24, 2011
    Date of Event
    February 16, 2010
    Report Date
    February 17, 2010
    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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT PROVIDE ANY DATA FOR REVIEW. SERVICE REPORTED THAT ALL HARDWARE WAS CURRENT AS OF THE PRIOR MONTH. THE CUSTOMER SERVICE REPRESENTATIVE DISCUSSED MAINTENANCE OF THE SYSTEM AND THE CUSTOMER REPORTED THAT THE GLUCOSE MODULE COVER WAS NOT PROPERLY SECURED. THE CUSTOMER REPORTS THAT THE SECURING HARDWARE IS NOT AVAILABLE. FAILURE TO PROPERLY MAINTAIN THE COVER IN ITS PROPER LOCATION WILL RESULT IN THE SAMPLING PROBE COMING INTO CONTACT WITH THE COVER THUS RESULTING IN A WICKING EFFECT OR SHORT SAMPLE SCENARIO. THIS IS ONE OF TWO MEDWATCH REPORTS AS THE CUSTOMER REPORTED THAT THIS EVENT OCCURRED OVER A PERIOD OF TWO DAYS. REFERENCE THE MDR NUMBERS BELOW FOR ALL ASSOCIATED EVENTS: 2050012-2011-02429. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN JANUARY 1, 2008 AND OCTOBER 23, 2010 FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THREE ERRONEOUSLY LOW GLUCOSE CUP RESULTS WERE GENERATED BY THE UNICEL DXC 600 SYNCHRON SYSTEM OVER A PERIOD OF TWO DAYS. NO SPECIFIC DATA RELATING TO ANY OF THE EVENTS WAS PROVIDED OR AVAILABLE, HOWEVER, CUSTOMER ADVISED THAT ONE RESULT RETURNED AN INITIAL RESULT OF <10 MG/DL AND BETWEEN 84-89 MG/DL ON RETEST. CUSTOMER STATED NO ISSUES RELATING TO QUALITY CONTROLS WERE ENCOUNTERED. THE INITIAL RESULTS WERE NOT DISSEMINATED FROM THE LABORATORY. THE LABORATORY RETESTED THE ORIGINAL SAMPLES ON ANOTHER INSTRUMENT AND OBTAINED RESULTS WITHIN EXPECTATION. THE RETESTED SAMPLE RESULTS WERE REPORTED. THERE WAS NO CHANGE TO THE PATIENTS' CARE OR TREATMENT RELATED TO THIS EVENT SINCE THE ORIGINAL LOW RESULTS WERE NOT REPORTED OUT OF THE LABORATORY.

    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