BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® HMX HEMATOLOGY ANALYER WITH AUTOLOADER

    MDR report key: 2301596 · Received October 20, 2011

    Report

    Report Number
    1061932-2011-01878
    Event Type
    Malfunction
    Date Received
    October 20, 2011
    Date of Event
    August 4, 2011
    Report Date
    August 4, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K010765
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2011. THE FSE REPLACED THE PROBE WIPE CYLINDER AND SPRING, CLEANED AND LUBED THE BALL SLIDE. REASSEMBLED AND VERIFIED REPAIR. SYSTEM WAS VALIDATED. PER LABELING, BECKMAN COULTER URGES ITS CUSTOMERS TO COMPLY WITH ALL NATIONAL HEALTH AND SAFETY STANDARDS SUCH AS THE USE OF BARRIER PROTECTION. THIS MAY INCLUDE, BUT IS NOT LIMITED TO, WEARING PROTECTIVE EYE WEAR, GLOVES, AND SUITABLE LABORATORY ATTIRE WHEN OPERATING OR MAINTAINING THIS INSTRUMENT OR ANY OTHER AUTOMATED LABORATORY ANALYZER. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BEC) TO REPORT THAT THE SECONDARY PROBE ON THE COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER (AL) WAS LEAKING. THE CUSTOMER WAS WEARING GLOVES AND A LAB COAT AT THE TIME OF THE EVENT. THERE WAS NO REPORT OF CONTACT WITH MUCOUS MEMBRANES OR OPEN WOUNDS. THE CUSTOMER STATED THAT NO SAMPLES WERE COMPROMISED AS A RESULT OF THE LEAK. THERE WAS NO DEATH, INJURY OR CHANGE TO PATIENT TREATMENT AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® HMX HEMATOLOGY ANALYER WITH AUTOLOADER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. HMX WITH AUTOLOADER NA

    Patients

    Seq Age Sex Outcome Treatment
    1