BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® HMX HEMATOLOGY ANALYZER W/ AUTOLOADER

    MDR report key: 3844477 · Received June 3, 2014

    Report

    Report Number
    1061932-2014-01259
    Event Type
    Malfunction
    Date Received
    June 3, 2014
    Date of Event
    May 4, 2014
    Report Date
    May 4, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K010765
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED. THE FSE CONFIRMED THE LEAK FROM FAULTY VALVE PV49 AND THE ASSOCIATED ACTUATOR. THE FSE REPLACED PV49 AND THE ASSOCIATED ACTUATOR RESOLVING THE LEAK. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED 2-3 DROPS OF FLUID LEAKED FROM THE BLOOD SAMPLING VALVE (BSV) DURING A BACKWASH CYCLE IN THE HMX AL INSTRUMENT. THE CUSTOMER ALSO REPORTED THE HMX AL GENERATED AN ERRONEOUS HIGH WHITE BLOOD CELL (WBC) COUNTS DURING THE EVENT. THE CUSTOMER DID NOT PROVIDE PRINTOUTS. HOWEVER, THE CUSTOMER REPORTED THE WBC COUNT ON A SINGLE PATIENT SAMPLE WAS THREE TIMES HIGHER THAN THE WBC ON THAT SAME SAMPLE RUN ON A DIFFERENT ANALYZER. THERE WERE NO ERRONEOUS RESULTS REPORTED OUT OF THE LABORATORY. THE CUSTOMER RAN AND REPORTED RESULTS FROM THE BACKUP ANALYZER DURING THE EVENT DUE TO THE LEAK OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323242 COULTER® HMX HEMATOLOGY ANALYZER W/ AUTOLOADER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1