BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 500 HEMATOLOGY INSTRUMENT

    MDR report key: 3128470 · Received May 23, 2013

    Report

    Report Number
    1061932-2013-00978
    Event Type
    Malfunction
    Date Received
    May 23, 2013
    Date of Event
    April 26, 2013
    Report Date
    April 27, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K032000
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2013 FOR THIS EVENT. THE FSE FOUND PROBE DRIPPING AND ADJUSTED THE PROBE WIPE MECHANISM TO REPAIR THE LEAK. FAILURE MODE IS THE PROBE WIPE 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) REPORTING LESS THAN 10 ML FLUID (THAT APPEARS TO BE DILUENT) DRIPPED FROM THE MANUAL SAMPLE PROBE IN THE COULTER LH 500 HEMATOLOGY INSTRUMENT. THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES, PROTECTIVE EYEWEAR, AND A LABORATORY COAT 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. MEDICAL ATTENTION WAS NOT SOUGHT. THE OPERATOR WAS RUNNING PATIENT SAMPLES AT THE TIME THE LEAK WAS OBSERVED; HOWEVER NO ERRONEOUS RESULTS WERE GENERATED IN CONNECTION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229450 COULTER® LH 500 HEMATOLOGY INSTRUMENT COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER LH 500 NA

    Patients

    Seq Age Sex Outcome Treatment
    1