BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2770100 · Received October 3, 2012

    Report

    Report Number
    2050012-2012-01738
    Event Type
    Malfunction
    Date Received
    October 3, 2012
    Date of Event
    September 13, 2012
    Report Date
    September 13, 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
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE FSE FOUND WATER SPILLED THROUGH THE REAGENT PROBE WASH COLLARS, AND REPLACED THE SOLENOID VALVES FOR REAGENT PROBE A AND B WHICH RESOLVED THE ISSUE. CAUSE FOR THE LEAK APPEARS TO BE THE SOLENOID VALVE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BEC), AND REPORTED THAT THEY FOUND A PUDDLE OF ABOUT 5 TO 6ML ON THE CUVETTE WHEEL COVER AND ON THE COVER OVER THE REAGENT CAROUSEL ON THEIR UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEM. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF A LAB COAT, GLOVES AND EYE PROTECTION. CUSTOMER USED PAPER TOWEL TO CLEAN UP THE LEAK. NO ONE WAS INJURED OR SOUGHT MEDICAL ATTENTION DUE TO THE LEAK. THE CUSTOMER ALSO STATED THAT ONE ERRONEOUS CREATININE (CR-S) RESULT WAS GENERATED. THE ORIGINAL CREATININE RESULT WAS 2UMOL/L AND WAS NOT REPORTED OUT OF THE LAB. THE PATIENT SAMPLE WAS RE-TESTED ON ANOTHER INSTRUMENT, AND REPEATED RESULT OF 51UMOL/L WAS REPORTED OUT OF THE LAB. THE CUSTOMER RERAN SOME PATIENT SAMPLES THAT WERE RUN AROUND THE TIME AS THE ERRONEOUS CREATININE RESULT WAS GENERATED, AND ALL OTHER RESULTS MATCHED. THE CUSTOMER SETUP THE INSTRUMENT TO FLAG AND NOTIFY ANY RESULTS THAT ARE <27UMOL/L. PATIENT TREATMENT WAS NOT AFFECTED IN CONNECTION WITH THIS EVENT. PER THE CUSTOMER, QC WAS RUN BEFORE THIS EVENT AND THE RESULTS WERE WITHIN THE ESTABLISHED RANGES. CONCURRENTLY WITH THIS EVENT, THE CUSTOMER WAS RUNNING URINE QC AND THE URINE QC WAS OUT OF RANGE FOR CREATININE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER INC. DXC 600 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR