BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600 SYNCHRON SYSTEM

    MDR report key: 2172304 · Received June 24, 2011

    Report

    Report Number
    2050012-2011-02413
    Event Type
    Malfunction
    Date Received
    June 24, 2011
    Date of Event
    January 21, 2010
    Report Date
    January 21, 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 FIELD SERVICE ENGINEER (FSE) VISITED THE FACILITY AND EXAMINED THE SYSTEM. INSTRUMENT MAINTENANCE RECORDS WERE CURRENT. THE FSE REPLACED THE GLUCOSE REAGENT PUMP AND THE SAMPLE SYRINGE AS A PRECAUTION. ALTHOUGH SEVERAL PARTS WERE REPLACED, THE SPECIFIC ROOT CAUSE OF THIS EVENT COULD NOT BE DETERMINED. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN (B)(6), 2008 AND (B)(6), 2010 FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT TWO ERRONEOUSLY LOW GLUCOSE CUP RESULTS WERE GENERATED BY THE UNICEL DXC 600 SYNCHRON SYSTEM. CALIBRATION AND QUALITY CONTROLS WERE ACCEPTABLE PRIOR TO THE EVENT. THE RESULTS WERE NOT DISSEMINATED FROM THE LABORATORY. THE LABORATORY RETESTED BOTH 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.

    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