BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM

    MDR report key: 3903325 · Received June 30, 2014

    Report

    Report Number
    1061932-2014-01515
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 4, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K081930
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SERVICE PERSONNEL DISCOVERED THAT THE BUFFER TO FEEDER VALVE (VL327) WAS FOUND TO BE DEFECTIVE ALLOWING DILUENT/CLEANER REAGENT TO FLOW INTO THE FEEDER CHAMBER (VC327) FROM THE BUFFER CHAMBER (VC330). VL327 WAS REPLACED, RESOLVING THE ISSUE. THE INSTRUMENT WAS VERIFIED WITH DAILY CHECK RESULTS RECOVERING WITHIN LIMITS AND PLATELET BACKGROUNDS RECOVERED WITHIN THE EXPECTED RANGE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN INCREASED PLATELET BACKGROUND FAILURE DURING THE DAILY CHECKS WHEN USING THE UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM. THERE WERE NO ERRONEOUS TEST RESULTS ASSOCIATED WITH THIS EVENT. THERE WAS NO DEATH, INJURY OR AFFECT TO USER OR PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379789 UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1