BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM

    MDR report key: 3982216 · Received August 5, 2014

    Report

    Report Number
    1061932-2014-01873
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 9, 2014
    Report Date
    July 9, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K120771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) ASSESSED THE DISTRIBUTION VALVE (DV) AND NOTED IT WAS NOT INITIATING CORRECTLY. THE FSE REPLACED THE DV AND VERIFIED SYSTEM OPERATION. THE FSE THEN EXAMINED THE LATRON CONTROL AND NOTED THE COEFFICIENT OF VARIATION (CV) WAS ELEVATED AND VALUES DRIFTED. THE FSE PERFORMED SYSTEM SHUTDOWN, CLEANED THE FLOWCELL, AND PERFORMED ANOTHER LATRON CONTROL; THE FSE NOTED THE CVS CONTINUED TO BE ELEVATED. THE FSE PERFORMED FLOWCELL ALIGNMENT AND WAS UNABLE TO GET A STEADY SETUP. THE FSE REPLACED THE FLOWCELL AND NOTED THE COMPUTER CONTINUED LOCKING OUT REPEATEDLY. THE FSE TURNED OFF THE LABORATORY INFORMATION SYSTEM (LIS) SYSTEM AND RESTARTED THE COMPUTER. THE FSE VERIFIED SYSTEM SETUP AND NOTED ALL TEST RESULTS WERE ACCEPTABLE. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS AND WAS RETURNED TO NORMAL OPERATION. IN CONCLUSION, THE LIKELY CAUSE OF THE EVENT WAS SYSTEM HARDWARE. THE DV SYSTEM ERROR WAS DUE TO A FAULTY DISTRIBUTION BOARD. THE LATRON CONTROL WAS DUE TO A FAULTY FLOWCELL. AND SYSTEM RESTART RESOLVED THE LIS SYSTEM ISSUE. (B)(4).

    Description of Event or Problem · 1

    THE AFFILIATE STATED THE CUSTOMER REPORTED DV DID NOT SENSE HOME SYSTEM ERRORS AND THE DISTRIBUTION VALVE WAS MAKING A LOUD GRINDING NOISE INVOLVING THE UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM. THE CUSTOMER INDICATED PATIENT RESULTS WERE NOT IMPACTED. THERE WAS NO PATIENT CONSEQUENCE 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
    457213 UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1