BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM

    MDR report key: 4508682 · Received February 11, 2015

    Report

    Report Number
    1061932-2015-00195
    Event Type
    Malfunction
    Date Received
    February 11, 2015
    Date of Event
    January 13, 2015
    Report Date
    January 13, 2015
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K140911
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT ON (B)(4) 2015. THE DIFF MIXING CHAMBER WAS REPLACED, AND THE REPAIRS WERE VERIFIED PER ESTABLISHED PROCEDURES. (B)(4).

    Description of Event or Problem · 1

    WHILE THE FIELD SERVICE ENGINEER (FSE) WAS AT THE CUSTOMER'S SITE TROUBLESHOOTING AN UNRELATED ISSUE, HE DISCOVERED A BLOODY DIFF MIXING CHAMBER ON A UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM, WHICH REQUIRED REPLACEMENT. ERRONEOUS PATIENT RESULTS WERE NOT GENERATED AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102136 UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1