BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 2180548 · Received July 27, 2011

    Report

    Report Number
    2050012-2011-03750
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    June 26, 2011
    Report Date
    June 26, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON CUSTOMER FEEDBACK, BEC HAS OPENED CAPA (B)(4) TO INVESTIGATE THE ROOT CAUSE OF A REAGENT SYRINGE COMING LOOSE FROM ITS CONNECTION TO A T-VALVE.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER, INC. (BEC) TO REPORT ERRONEOUSLY LOW RESULTS FOR IRON, GLUCOSE, AND TRANSFERRING BETWEEN TWO (2) PATIENTS ON THEIR UNICEL DXC 600 PRO SYNCHRON CHEMISTRY ANALYZER. THE ERRONEOUSLY LOW PATIENT SAMPLE RESULTS WERE REPORTED OUT OF THE LABORATORY. THE CUSTOMER REPORTED THAT THERE WAS NO IMPACT TO PATIENT TREATMENT. THE CUSTOMER PROVIDED DATA PERTAINING TO THE ERRONEOUS RESULTS REPORTED OUT OF THE LABORATORY FOR IRON AND GLUCOSE. NO SPECIFIC DATA WAS PROVIDED BY THE CUSTOMER FOR THE ERRONEOUS TRANSFERRIN RESULTS. THE PATIENT SAMPLES WERE RE-ASSAYED ON A SECOND ANALYZER AND AMENDED REPORTS WERE GENERATED TO CAPTURE THESE REPEAT RESULTS. THE CUSTOMER OBSERVED LIQUID ON THE COVER BELOW THE PROBE WASH COLLAR. THE CUSTOMER DID NOT DETERMINE THE CAUSE OF THE LEAK AND HAD REQUESTED SERVICE. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S SITE ON (B)(4) 2011. THE FSE OBSERVED THAT THE 3-WAY VALVE FOR THE SAMPLE PROBE WAS LEAKING. THE FSE REPLACED THE 3-WAY VALVE AND THEN RAN QUALITY CONTROLS WITH NO ERRORS OBSERVED. THE ANALYZER REPAIR WAS VERIFIED PER ESTABLISHED PROCEDURES. THE ROOT CAUSE OF THE ERRONEOUS RESULTS FOR IRON, GLUCOSE, AND TRANSFERRING IS ATTRIBUTED TO THE LEAKING 3-WAY VALVE FOR THE SAMPLE PROBE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1