BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2874439 · Received December 14, 2012

    Report

    Report Number
    2050012-2012-01904
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Date of Event
    November 20, 2012
    Report Date
    November 20, 2012
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    QC WAS RUN BEFORE THE EVENT AND RESULTS WERE WITHIN THE ESTABLISHED RANGES. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE FSE INSPECTED THE INSTRUMENT AND CONFIRMED THERE WAS NO VISUAL PRECIPITATE OR CLOUDINESS IN THE CREATININE REAGENT BOTTLE. THE FSE FOUND THE TRICONTINENT SYRINGE WAS SHOWING MINIMAL WEAR AND REPLACED THE SYRINGE. PER FSE, THE MODULE WAS FILLING AND WAS STIRRING APPROPRIATELY. THE FSE CALIBRATED THE CREM LAMP AND REPLACED THE MODULAR CHEMISTRY (MC) SAMPLE PROBE WHICH RESOLVED THE ISSUE. FAILURE MODE OF THIS EVENT IS UNKNOWN. THE FSE REPLACED PARTS AND CALIBRATED THE CREM LAMP; ANY OF WHICH COULD CONTRIBUTE TO THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) AND REPORTED THAT FALSE HIGH CREATININE (CREM) RESULTS WERE GENERATED ON THE UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEM. CUSTOMER INDICATED THAT THE SYSTEM WAS SETUP TO PERFORM CRITICAL RERUN FOR RESULTS THAT ARE GREATER THAN 2.99MG/DL. ALL RERUNS WERE PERFORMED ON THE SAME INSTRUMENT. THE CUSTOMER PROVIDED DATA INVOLVED THREE PATIENT SAMPLES. THIS REPORT IS TO DOCUMENT PATIENT RESULTS OBTAINED ON (B)(6) 2012. AN MDR # 2050012-2012-01905 IS BEING SUBMITTED FOR EVENT OCCURRED AT THE CUSTOMER SITE ON (B)(6) 2012. THE FALSE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. NO IMPACT TO PATIENT TREATMENT WAS REPORTED IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER INC. DXC 800 PRO

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR