BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM

    MDR report key: 3885233 · Received June 19, 2014

    Report

    Report Number
    1061932-2014-01399
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 27, 2014
    Report Date
    May 27, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K081930
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) /2014, THE FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT AND IDENTIFIED A LEAK NEAR THE PROBE DURING DAILY CHECKS. THE FSE REPLACED THE PROBE (USER REPLACEABLE PART) DUE TO A BEND IN THE SHAFT. THE FSE ALSO REPLACED THE PROBE WASH COLLAR DUE TO A CRACK IN THE PLASTIC, WHICH WAS CAUSING THE LEAK. MULTIPLE DAILY CHECKS, 6C CONTROLS AND PATIENT SAMPLES WERE ALL RAN WITHOUT ISSUE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LEAK WHEN USING THE UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM. THE PROBE/WASH COLLAR WAS LEAKING LESS THAN 2CC OF DILUENT AND SAMPLE ONTO THE TOPS OF TUBES INSIDE THE INSTRUMENT. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER'S FACILITY TO EVALUATE THE INSTRUMENT. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT OF GLOVES AND A LAB COAT. THERE WERE NO REPORTS OF BIOHAZARD EXPOSURE TO MUCOUS MEMBRANES OR CUTS. 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
    361094 UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1