BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2180454 · Received July 27, 2011

    Report

    Report Number
    2050012-2011-03844
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    June 28, 2011
    Report Date
    June 28, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLES WERE SERUM. AFTER LEAKING WAS DISCOVERED ON THE CAPS, THE CUSTOMER RAN QC FOR ALL MODULAR AND CARTRIDGE CHEMISTRIES. ALL RESULTS WERE ACCEPTABLE. ON (B)(4) 2011, BEC FIELD SERVICE ENGINEER (FSE) PERFORMED A PREVENTIVE MAINTENANCE AS SCHEDULED. THE FSE PRIMED THE INSTRUMENT AND NOTED A DROP OF LIQUID HANGING ON THE MODULAR CHEMISTRY (MC) SAMPLE PROBE. THE FSE CHECKED ALL CONNECTIONS AND REPLACED THE SAMPLE SYRINGE PLUNGER. ALL ISE (ION-SELECTIVE ELECTRODE) CALIBRATION AND PRECISION VERIFICATION TESTS PASSED THE SPECIFICATIONS. THE REPAIR WAS VERIFIED PER ESTABLISHED PROCEDURES.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER INC. (BEC) THAT THE UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER GENERATED ERRONEOUSLY HIGH SODIUM (NA), POTASSIUM (K), CHLORIDE (CL), AND CARBON DIOXIDE (CO2) RESULTS. THE CUSTOMER ALSO REPORTED TO BEC THAT THE CAP PIERCER BLADE WASH WAS LEAKING ONTO TUBE CAPS. THE CUSTOMER REPEATED PATIENT SAMPLES ON AN ALTERNATE INSTRUMENT. MOST RESULTS MATCHED, BUT SOME RESULTS WERE DISCREPANT AND REQUIRED AMENDED REPORTS AS THEY HAD BEEN REPORTED OUT OF THE LABORATORY. THE PATIENT RESULTS ARE SHOWN. THE CUSTOMER REPORTED THAT THERE WAS NO EFFECT TO PATIENTS AND USERS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1