BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 660I SYNCHRON ACCESS CLINICAL SYSTEM

    MDR report key: 3870872 · Received June 12, 2014

    Report

    Report Number
    2050012-2014-00301
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Date of Event
    May 21, 2014
    Report Date
    May 21, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) DISCOVERED LOOSE TUBING AT THE OBSTRUCTION DETECTION AND CORRECTION (ODC) ON THE MODULAR CHEMISTRY (MC) SAMPLE PROBE. THE FSE CLEANED THE FLOWCELL AND REPLACED THE SODIUM ELECTRODES BUT DID NOT RESOLVE THE ISSUE. THE FSE THEN TIGHTENED THE LOOSE TUBING AND RESOLVED THE REPORTED ISSUES. SERVICE ACTIVITY PERFORMED WAS VERIFIED PER SPECIFICATIONS. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS AND WAS RETURNED TO NORMAL OPERATION. IN CONCLUSION, THE LIKELY CAUSE OF THE EVENT IS ATTRIBUTED TO THE LOOSE TUBING AT THE ODC DEVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED LOW MODULAR GLUCOSE (GLUCM) RESULTS AND FAILED ION-SELECTIVE ELECTRODE (ISE) CALIBRATION DUE TO RANGE, SPAN, AND BACK-TO-BACK SYSTEM ERRORS INVOLVING THE UNICEL DXC 660I SYNCHRON ACCESS CLINICAL SYSTEM. IN ADDITION, THE CUSTOMER STATED THE INSTRUMENT GENERATED THREE ERRONEOUSLY LOW SODIUM (NA) PATIENT RESULTS. THE CUSTOMER REANALYZED THE SAMPLES ON AN ALTERNATE UNICEL DXC SYSTEM AND RECOVERED NORMAL GLUCOSE AND SODIUM RESULTS. THE CUSTOMER STATED THE LOW GLUCOSE AND SODIUM RESULTS WERE NOT RELEASED OUT OF THE LABORATORY. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT. THE CUSTOMER PERFORMED SYSTEM DIAGNOSTICS AND NOTICED THE MODULAR CHEMISTRY (MC) SAMPLE PROBE OBSTRUCTION DETECTION AND CORRECTION (ODC) DEVICE WAS LEAKING APPROXIMATELY ONE MILLILITER OF WATER FROM THE TRANSDUCER. THE OPERATOR WAS WEARING PROPER PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES, A LABORATORY COAT, AND EYE PROTECTION AND DID NOT HAVE DIRECT CONTACT WITH THE FLUID. THERE WAS NO OPERATOR INJURY OR ADVERSE EFFECT ASSOCIATED WITH THIS EVENT. BECKMAN COULTER ADVISED THE CUSTOMER TO REANALYZE PREVIOUSLY TESTED PATIENT SAMPLES UP TO THE LAST ACCEPTABLE QUALITY CONTROL (QC) TO VERIFY THE ACCURACY AND PRECISION OF THE RESULTS. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347145 UNICEL DXC 660I SYNCHRON ACCESS CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1