BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEMS

    MDR report key: 2042695 · Received April 6, 2011

    Report

    Report Number
    2050012-2011-00963
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    February 16, 2011
    Report Date
    February 21, 2011
    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
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CALIBRATION HAD FAILED PRIOR TO CONFIRMING THE PATIENT RESULTS. CUSTOMER CALIBRATES AND RUNS QC EVERY 8 HOURS. GLUCOSE CUP MAINTENANCE HAD RECENTLY BEEN PERFORMED. ELECTRODE IS WITHIN ON-BOARD DATING OF 6 MONTHS. SERVICE UPDATED THE INSTRUMENT WITH THE GLUCM MODIFICATIONS FOR THE STIRRER MOTOR AND SAMPLE WHEEL COVER. ROOT CAUSE OF THIS EVENT IS UNKNOWN. PATIENT #2 INFORMATION:AN ADULT MALE, (B)(6).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI), AND REPORTED THAT TWO GLUCOSE (GLUCM) PATIENT RESULTS RUN IN DUPLICATE MODE ON UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEMS DID NOT MATCH. THE SPECIMENS WERE RE-TESTED ON SAME INSTRUMENT AND OBTAINED RESULTS DID NOT CORRELATE WITH THE INITIAL GLUCM RESULTS. THE DISCREPANT RESULTS WERE NOT REPORTED OUT OF THE LAB. CUSTOMER COULD NOT PROVIDE THE ACTUAL RESULTS THAT WERE REPORTED. PATIENT TREATMENT WAS NOT AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEMS CLINICAL CHEMISTRY ANALYZER CGA BECKMAN COULTER INC. DXC 600 PRO

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR