BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM

    MDR report key: 3911231 · Received July 2, 2014

    Report

    Report Number
    1061932-2014-01504
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    June 8, 2014
    Report Date
    June 8, 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

    A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT. THE FSE DISCOVERED A SMALL (E- CLIP) WASHER FROM A PREVIOUS PROBE STUCK UNDERNEATH THE WASH COLLAR PREVENTING THE PROPER VERTICAL ALIGNMENT OF THE PROBE WASH ASSEMBLY. THE FSE REPLACED THE MISALIGNED PROBE WIPE ASSEMBLY TO RESOLVE THE LEAK ISSUE. THE FSE VERIFIED THE INSTRUMENT AND THE INSTRUMENT WAS RETURNED TO NORMAL OPERATION. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED DRIED BLOODY FLUID LEAKED FROM THE UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM. THE VOLUME OF THE LEAK IS UNKNOWN. THE LEAK WAS CONTAINED WITHIN THE INSTRUMENT. THE OPERATOR WAS WEARING GLASSES, GLOVES, AND A LAB COAT AT THE TIME OF THE INCIDENT. THERE WAS NO REPORTED EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. NO ERRONEOUS PATIENT RESULTS WERE GENERATED IN CONNECTION WITH THIS EVENT. THERE WAS NO DEATH, INJURY, OR AFFECT TO USER OR TO PATIENT TREATMENT ATTRIBUTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385929 UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1