BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX20 PRO CLINICAL SYSTEM

    MDR report key: 2180912 · Received July 1, 2011

    Report

    Report Number
    2050012-2011-02685
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    April 29, 2010
    Report Date
    April 30, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    CGA
    PMA / PMN Number
    K011213
    Removal / Correction Number
    Z-2388-2010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SERVICE CALL WAS PLACED, HOWEVER, THE CUSTOMER CANCELED THE CALL, AND ACCORDINGLY, NO DEVICE EVALUATION WAS CONDUCTED. THE CUSTOMER PROVIDED QUALITY CONTROL RESULTS; THE RESULTS WERE WITHIN ESTABLISHED LABORATORY SPECIFICATIONS. NO ROOT CAUSE OR CONCLUSION COULD BE DRAWN. 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 ERRONEOUS GLUCOSE RESULTS WERE GENERATED BY THE SYNCHRON LX20 PRO CLINICAL SYSTEM. THE SYSTEM GENERATED CRITICAL RE-RUN FEATURE WAS TRIGGERED. THE INITIAL ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THE CUSTOMER RETESTED THE SAMPLES ON THE SAME SYSTEM AND OBTAINED RESULTS CONSISTENT WITH EXPECTATIONS. THERE WAS NO CHANGE TO THE PATIENTS' CARE OR TREATMENT.

    Additional Manufacturer Narrative · 2

    A SERVICE CALL WAS PLACED, HOWEVER, THE CUSTOMER CANCELED THE CALL, AND ACCORDINGLY, NO DEVICE EVALUATION WAS CONDUCTED. THE CUSTOMER PROVIDED QUALITY CONTROL RESULTS; THE RESULTS WERE WITHIN ESTABLISHED LABORATORY SPECIFICATIONS. NO ROOT CAUSE OR CONCLUSION COULD BE DRAWN. 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 · 2

    CUSTOMER REPORTED THAT ERRONEOUS GLUCOSE RESULTS WERE GENERATED BY THE SYNCHRON LX20 PRO CLINICAL SYSTEM. THE SYSTEM GENERATED CRITICAL RE-RUN FEATURE WAS TRIGGERED. THE INITIAL ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THE CUSTOMER RETESTED THE SAMPLES ON THE SAME SYSTEM AND OBTAINED RESULTS CONSISTENT WITH EXPECTATIONS. THERE WAS NO CHANGE TO THE PATIENTS' CARE OR TREATMENT.

    Additional Manufacturer Narrative · 3

    A SERVICE CALL WAS PLACED, HOWEVER, THE CUSTOMER CANCELED THE CALL, AND ACCORDINGLY, NO DEVICE EVALUATION WAS CONDUCTED. THE CUSTOMER PROVIDED QUALITY CONTROL RESULTS; THE RESULTS WERE WITHIN ESTABLISHED LABORATORY SPECIFICATIONS. NO ROOT CAUSE OR CONCLUSION COULD BE DRAWN. 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 · 3

    CUSTOMER REPORTED THAT ERRONEOUS GLUCOSE RESULTS WERE GENERATED BY THE SYNCHRON LX20 PRO CLINICAL SYSTEM. THE SYSTEM GENERATED CRITICAL RE-RUN FEATURE WAS TRIGGERED. THE INITIAL ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THE CUSTOMER RETESTED THE SAMPLES ON THE SAME SYSTEM AND OBTAINED RESULTS CONSISTENT WITH EXPECTATIONS. THERE WAS NO CHANGE TO THE PATIENTS' CARE OR TREATMENT.

    Additional Manufacturer Narrative · 4

    A SERVICE CALL WAS PLACED, HOWEVER, THE CUSTOMER CANCELED THE CALL, AND ACCORDINGLY, NO DEVICE EVALUATION WAS CONDUCTED. THE CUSTOMER PROVIDED QUALITY CONTROL RESULTS; THE RESULTS WERE WITHIN ESTABLISHED LABORATORY SPECIFICATIONS. NO ROOT CAUSE OR CONCLUSION COULD BE DRAWN. 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 · 4

    CUSTOMER REPORTED THAT ERRONEOUS GLUCOSE RESULTS WERE GENERATED BY THE SYNCHRON LX20 PRO CLINICAL SYSTEM. THE SYSTEM GENERATED CRITICAL RE-RUN FEATURE WAS TRIGGERED. THE INITIAL ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THE CUSTOMER RETESTED THE SAMPLES ON THE SAME SYSTEM AND OBTAINED RESULTS CONSISTENT WITH EXPECTATIONS. THERE WAS NO CHANGE TO THE PATIENTS' CARE OR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON LX20 PRO CLINICAL SYSTEM CGA BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR
    2 42 YR
    3 73 YR
    4 22 YR