BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM

    MDR report key: 3870888 · Received June 12, 2014

    Report

    Report Number
    1061932-2014-01354
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Date of Event
    May 26, 2014
    Report Date
    May 26, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K081930
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) OBSERVED CHECK VALVE CV150 WAS NOT CLOSING PROPERLY CAUSING BACKFLOW IN THE SWEEP FLOW SUPPLY LINE DURING SYSTEM IDLE. THE FSE REPLACED CHECK VALVE CV150 AND RESOLVED THE REPORTED ISSUE. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS AND WAS RETURNED TO NORMAL OPERATION. IN CONCLUSION, THE LIKELY CAUSE OF THE EVENT IS ATTRIBUTED TO CHECK VALVE CV150.

    Description of Event or Problem · 1

    THE AFFILIATE STATED THE CUSTOMER REPORTED LOW RED BLOOD CELL (RBC) AND PLATELET RESULTS ON 6C CELL CONTROL INVOLVING THE UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM. THE CUSTOMER STATED PATIENT RESULTS WERE NOT IMPACTED; NO ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347508 UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1