BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS CLINICAL SYSTEM

    MDR report key: 3151044 · Received June 6, 2013

    Report

    Report Number
    2050012-2013-00370
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    May 11, 2013
    Report Date
    May 12, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED REPLACING THE ISE (ION SELECTIVE ELECTRODE) REAGENTS AND PERFORMED THE TWICE-WEEKLY MAINTENANCE TO RESOLVE THE HIGH NA AND LOW CL ISSUE PRIOR TO REPORTING THE EVENT TO BECKMAN COULTER. THE CUSTOMER STILL HAD AN ISSUE WITH CALC RESULTS AND A BECKMAN COULTER CTS (CUSTOMER TECHNICAL SUPPORT) ASSISTED THE CUSTOMER WITH TROUBLESHOOTING OVER THE PHONE. THE CTS ADVISED THE CUSTOMER TO DRAIN THE ISE MODULE, REMOVE THE NA, CL AND CALC ELECTRODES, AND CLEAN THE PORTS TO RESOLVE THE ISSUE. THE CTS ALSO INSTRUCTED THE CUSTOMER TO RE-ASSEMBLE, PRIME AND CALIBRATE THE INSTRUMENT WITH FRESH CALIBRATOR. FAILURE MODE IS UNKNOWN BUT THE ISSUE WAS RESOLVED THROUGH ROUTINE TROUBLESHOOTING. A BECKMAN COULTER FSE (FIELD SERVICE ENGINEER) WAS NOT DISPATCHED FOR THIS EVENT AS THE CUSTOMER RESOLVED THE ISSUE WITH THE HELP OF A CTS OVER THE PHONE. ISSUE WAS RESOLVED BY THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED GENERATING AN ERRONEOUSLY HIGH NA (SODIUM) AND CALC (CALCIUM), AND AN ERRONEOUSLY LOW CL (CHLORIDE) RESULT FOR ONE (1) PATIENT SAMPLE INVOLVING THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. THE CUSTOMER REPORTED THE NA AND CALC RESULTS OUT OF THE LABORATORY BUT THE CL RESULT WAS CRITICALLY LOW AND WAS NOT REPORTED OUT OF THE LABORATORY. THE CUSTOMER REPEATED THE SAMPLE ON AN ALTERNATE DXC INSTRUMENT AND ON THE ORIGINAL INSTRUMENT AFTER TROUBLESHOOTING AND ISSUED AMENDED REPORTS. THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. QC (QUALITY CONTROL) RESULTS 8 HOURS PRIOR TO THE EVENT WAS WITHIN THE LABORATORY'S ESTABLISHED RANGES. HIGH LEVEL NA QC AFTER THE EVENT WAS GREATER THAN 2 STANDARD DEVIATIONS HIGH AND BOTH LEVELS OF CL QC DRIFTED LOW AT GREATER THAN 4 STANDARD DEVIATIONS. IN ADDITION, HIGH LEVEL CALC QC WAS GREATER THAN 4 STANDARD DEVIATIONS HIGH FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251543 UNICEL® DXC 600I SYNCHRON® ACCESS CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR