BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2853867 · Received December 3, 2012

    Report

    Report Number
    2050012-2012-01870
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Date of Event
    November 8, 2012
    Report Date
    November 8, 2012
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER ORIGINALLY CONTACTED BEC ON (B)(4) 2012 WITH CO2 DAC ERRORS (FAILURE TO CALIBRATE AND/OR SUPPRESSED RESULTS). HOTLINE HAD THE CUSTOMER REPLACE THE CO2 MEMBRANE AND CO2 ALKALINE BUFFER REAGENT. UPON HOTLINE FOLLOW-UP ON (B)(4) 2012, THE CUSTOMER REPORTED THAT THE SYSTEM CALIBRATED AND QC CAME INTO RANGE, BUT WERE NOW HAVING HIGH PATIENT RESULTS FOR CO2 AND NA. AFTER THE EVENT, THE CUSTOMER INDICATED THAT QC WAS ALSO HIGH. QC DATA WAS REQUESTED BUT NOT PROVIDED. BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE FSE REPLACED THE NA ELECTRODES AND THE QUAD RINGS ON THE CO2 ELECTRODES. THE FSE ALSO REPLACED THE ELECTROLYTE INJECTION CUP (EIC) VALVES. FAILURE MODE FOR THIS EVENT WAS NOT IDENTIFIED. MULTIPLE PARTS WERE REPLACED, ANY OF WHICH COULD HAVE CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC, (BEC) AND REPORTED THAT THE UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEM GENERATED FALSE HIGH CARBON DIOXIDE (CO2) AND SODIUM (NA) RESULTS. RESULTS WERE NOT REPORTED OUT OF THE LAB. THE SAMPLES WERE RERUN ON ANOTHER DXC ANALYZER IN THE CUSTOMER LAB AND THOSE RESULTS WERE REPORTED. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN THE DATA. THE CUSTOMER PROVIDED 1 VERBAL EXAMPLE OF AN ORIGINAL CO2 RESULT OF 43 MMOL/L THAT RECOVERED 25 MMOL/L ON THE OTHER DXC INSTRUMENT. THE CUSTOMER ALSO SUPPLIED 1 VERBAL RESULT OF AN ORIGINAL NA OF 150 MMOL/L THAT RERAN AS 135 MMOL/L. NO OTHER RESULTS OR DETAILS WERE PROVIDED. NEITHER DEATH NOR INJURY WAS REPORTED IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER INC. DXC 600 PRO N/A

    Patients

    Seq Age Sex Outcome Treatment
    1