BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 500 INSTRUMENT

    MDR report key: 2851878 · Received November 29, 2012

    Report

    Report Number
    1061932-2012-02788
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    November 2, 2012
    Report Date
    November 2, 2012
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKZ
    PMA / PMN Number
    K032000
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2012 FOR THIS EVENT. FOUND A LEAK AT THE PROBE OF THE INSTRUMENT. THE FSE NOTICED THAT THE PROBE WAS BENT AND THE PROBE WIPE RINSE BLOCK WAS MISALIGNED. THE FSE REPLACED THE PROBE AND THE PROBE WIPE RINSE BLOCK AND THE LEAK WAS FIXED. THE REPAIRS WERE VERIFIED PER ESTABLISHED PROCEDURES. AS PER PRODUCT LABELING, BECKMAN COULTER, INC. 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 INC. (BEC) REPORTING A LEAK AT THE PROBE OF THE COULTER LH 500 INSTRUMENT. THE VOLUME OF THE LEAK WAS ABOUT 3 ML AND WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER WAS WEARING PERSONAL PROPER EQUIPMENT (PPE) CONSISTING OF GLOVES AND A LAB COAT AT THE TIME OF THE OCCURRENCE. THERE WAS NO BIOHAZARD EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. MEDICAL ATTENTION WAS NOT SOUGHT. THERE WERE NO ERRONEOUS RESULTS IN CONNECTION WITH THE LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® LH 500 INSTRUMENT COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER INC. LH 500 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1