BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 3033951 · Received April 3, 2013

    Report

    Report Number
    2050012-2013-00214
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 10, 2013
    Report Date
    March 10, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JGS
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE ON (B)(4) 2013. THE FSE CLEANED THE EIC (ELECTROLYTE INJECTION CUP) AND REPLACED THE QUAD RING AND SPACER; CLEANED FLOWCELL AND REPLACED CARBON BRIDGE. ON (B)(6) 2013, THE CUSTOMER REPORTED THAT THEY WERE STILL GETTING INTERMITTENT HIGH RECOVERY, BUT NO RESULTS WERE CONSIDERED ERRONEOUS AT THAT TIME. THE FSE WENT TO THE CUSTOMER'S LABORATORY AND DISCOVERED THAT LINE #13 (ION SELECTIVE ELECTRODE (ISE) BUFFER REAGENT LINE) DEVELOPED AIR BUBBLES AS THE INSTRUMENT SAT IDLE. THE FSE REPLACED THE RATIO PUMP AND AS OF (B)(4) 2013, THE CUSTOMER HAS NOT REPORTED ANY FURTHER PROBLEMS WITH THIS INSTRUMENT. THE RATIO PUMP WAS RETURNED TO BECKMAN COULTER AND TESTED. THE INTERNAL TESTING CONFIRMED THAT THE FAILURE MODE OF THIS EVENT WAS THE RATIO PUMP.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER, (BEC), THAT THE UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEM GENERATED FALSE HIGH SODIUM (NA), CHLORIDE (CL), AND CARBON DIOXIDE (CO2) RESULTS ON THREE (3) PATIENT SAMPLES. THE RESULTS WERE REPORTED OUT OF THE LABORATORY. WHEN THE ISSUE WAS NOTICED, THE SAMPLES WERE RERUN ON ANOTHER DXC AND LX20 ANALYZERS IN THE CUSTOMER'S LABORATORY AND PATIENT REPORTS WERE AMENDED. NA AND CO2 QUALITY CONTROL (QC) PRIOR TO THE EVENT WERE WITHIN THE LABORATORY ESTABLISHED RANGES, BUT THE LOW LEVEL OF QC HAD A HIGH OUTLIER EARLIER IN THE DAY, > 2 S.D (STANDARD DEVIATION). QC WAS NOT RUN AFTER THE EVENT. THE ANALYZER WAS RECALIBRATED AND NA AND CO2 QC RECOVERED ACCEPTABLY, BUT CL QC SHOWED SOME IMPRECISION; HOWEVER, WAS STILL WITHIN THE LABORATORY'S ESTABLISHED RANGES. NEITHER DEATH NOR INJURY WAS REPORTED IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137010 UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JGS BECKMAN COULTER DXC 800 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR