BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM

    MDR report key: 3962083 · Received July 28, 2014

    Report

    Report Number
    1061932-2014-01752
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    June 29, 2014
    Report Date
    June 29, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K120771
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT AND REPLACED THE PELTIER TO RESOLVE THE ISSUE. IN ADDITION, THE FSE CLEANED THE RETICULOCYTE MIX CHAMBER, ADJUSTED THE PHASE AND GAIN, DEFRAGMENTED THE CD DRIVE, AND REPLACED THE FLOWCELL WITH SAMPLE LINE, BCSN PREAMP, AND RETICULOCYTE SAMPLE LINE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM HAD AN ONGOING ISSUE WITH LATRON RECOVERING HIGH AND OUT OF SPECIFICATION ON VOLUME AND CONDUCTIVITY CHANNELS. THERE WERE NO ERRONEOUS RESULTS REPORTED OUT OF THE LABORATORY AND THERE WAS NO IMPACT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438011 UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1