BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 500 HEMATOLOGY INSTRUMENT

    MDR report key: 3325896 · Received September 4, 2013

    Report

    Report Number
    1061932-2013-01935
    Event Type
    Malfunction
    Date Received
    September 4, 2013
    Date of Event
    August 15, 2013
    Report Date
    August 15, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K042724
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(6) 2013 TO EVALUATE THE INSTRUMENT. THE FSE FOUND THE SAMPLE PROBE WAS OUT OF ALIGNMENT CAUSING THE LEAK OF CLEAR FLUID. THE FSE ADJUSTED THE PROBE RINSE BLOCK STOP FOR PROPER PROBE ALIGNMENT RESOLVING THE LEAK. THE FAILURE MODE IS SAMPLE PROBE WAS OUT OF ALIGNMENT. 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 IT IS NOT LIMITED TO, PROTECTIVE EYEWEAR, GLOVES, AND SUITABLE LABORATORY ATTIRE WHEN OPERATING OR MAINTAINING THIS OR ANY OTHER AUTOMATED LABORATORY ANALYZER. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER (BEC) REPORTED A LEAK OF CLEAR FLUID (2 ML) ONTO THE COUNTER WHILE RUNNING SAMPLES IN THE MANUAL MODE ON THE COULTER LH 500 HEMATOLOGY INSTRUMENT. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF A LABORATORY COAT, GLOVES, AND PROTECTIVE EYEWEAR AT THE TIME OF OCCURRENCE. THE MATERIAL SAFETY DATA SHEET (MSDS) WAS NOT REVIEWED. THE LABORATORY'S EXPOSURE CONTROL/RISK MANAGEMENT PLANS ARE IN PLACE. THERE WAS NO BIOHAZARD EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. THE OPERATOR DID NOT SEEK MEDICAL ATTENTION. NO ERRONEOUS RESULTS WERE GENERATED IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438853 COULTER® LH 500 HEMATOLOGY INSTRUMENT COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER LH 500 NA

    Patients

    Seq Age Sex Outcome Treatment
    1