BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 2080914 · Received May 7, 2011

    Report

    Report Number
    2050012-2011-01437
    Event Type
    Malfunction
    Date Received
    May 7, 2011
    Date of Event
    April 7, 2011
    Report Date
    April 7, 2011
    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
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER DID NOT PROVIDE INFORMATION ON SAMPLE COLLECTION AND STORAGE. WHEN LOW RESULT WAS NOTICED, CUSTOMER REPLACED REAGENT AND RECALIBRATED, BUT CALIBRATION FAILED. CALIBRATION AFTER ADDITIONAL TROUBLESHOOTING ALSO FAILED. BSI FIELD SERVICE ENGINEER (FSE) NOTICED THAT THE ALKALINE BUFFER PERI-PUMP WAS INTERMITTENTLY WORKING AND REPLACED IT. FSE ALSO REPLACED A DAMAGED CO2 ELECTRODE RETAINER NUT AND PERFORMED THE EIC VALVE REPLACEMENT MODIFICATION. FSE VERIFIED PERFORMANCE AFTER SERVICE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT A FALSE LOW CO2 RESULT OF 9 MMOL/L, GENERATED BY THE UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER. RESULT WAS NOT REPORTED OUT OF THE LAB. REPEAT TESTING OF THE SAMPLE ON AN ALTERNATE INSTRUMENT GENERATED A CO2 IN THE NORMAL RANGE. THE CUSTOMER COULD NOT PROVIDE THE ACTUAL RESULT. NO REPORT OF DEATH OR INJURY HAVE BEEN REPORTED IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXC 800 PRO N/A

    Patients

    Seq Age Sex Outcome Treatment
    1