BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 800 SYNCHRON SYSTEM

    MDR report key: 2172284 · Received June 24, 2011

    Report

    Report Number
    2050012-2011-02566
    Event Type
    Malfunction
    Date Received
    June 24, 2011
    Date of Event
    April 15, 2010
    Report Date
    April 21, 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SERVICE CALL WAS INITIATED OR SYSTEM EVALUATION CONDUCTED BY THE MANUFACTURER. THE CUSTOMER CONTACT REPRESENTATIVE DISCUSSED SEVERAL POSSIBLE CAUSES OF THE EVENT WITH THE CUSTOMER INCLUDING PROPER OUT-GASSING OF THE REAGENT AND PROPER MODULE COVER SEATING. THE CUSTOMER DOES NOT PROPERLY SECURE THE SYSTEM COVERS; ACCORDINGLY, THE CUSTOMER CONTACT REPRESENTATIVE SUGGESTED THAT THE CUSTOMER PROPERLY SECURE THE COVERS. SINCE NO EXAMINATION OF THE SYSTEM WAS CONDUCTED A DEFINITIVE ROOT CAUSE OF THIS EVENT COULD NOT BE DETERMINED. THIS IS ONE OF THREE MEDWATCH REPORTS AS THE CUSTOMER REPORTED THREE SEPARATE INCIDENTS. REFERENCE THE MDR NUMBERS BELOW FOR ALL ASSOCIATED EVENTS: MDR # 2050012-2010-00252, MDR # 2050012-2011-02565. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN (B)(4) 2008 AND (B)(4) 2010 FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT AN ERRONEOUSLY LOW GLUCOSE RESULT WAS GENERATED BY THE UNICEL DXC 800 SYNCHRON SYSTEM. THE SYSTEM GENERATED CRITICAL RE-RUN FEATURE WAS TRIGGERED AND RETURNED A RESULT WITHIN EXPECTATIONS. THE SAMPLE WAS RE-TESTED AND RETURNED A RESULT WITHIN EXPECTATIONS AND REPORTED OUT OF THE LABORATORY. QUALITY CONTROLS PRIOR TO AND AFTER THE EVENT WERE WITHIN LABORATORY SPECIFICATIONS. THE ORIGINAL RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY; ACCORDINGLY, THERE WAS NO CHANGE TO THE PATIENTS' 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 UNK LX GLUCOSE 2X2L