BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 500 HEMATOLOGY ANALYZER

    MDR report key: 3031834 · Received April 2, 2013

    Report

    Report Number
    1061932-2013-00532
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 7, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K032000
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) FOUND THAT THE LEAK OCCURRED AFTER THE CUSTOMER USED STREK LIN-C HIGH WHITE BLOOD CELL (WBC) PRODUCT FOR CONTROLS THAT IS NOT RECOMMENDED TO USE ON THIS ANALYZER. THE FSE ASSISTED THE CUSTOMER OVER THE PHONE AND HAD THE CUSTOMER TO BLEACH THE BLOOD SAMPLE VALVE (BSV) TO REMOVE A CLOG. AFTER BLEACHING THE BSV THE LEAK WAS FIXED AND THE UNIT WAS OPERATIONAL. FAILURE MODE WAS A CLOG AT THE BSV CAUSED BY A USER ERROR BASED ON USING UNAPPROVED CONTROLS. EACH INSTRUMENT HAS A LIST OF CONTROLS THAT BECKMAN COULTER RECOMMENDS TO OUR CUSTOMERS. THE APPROVED CONTROLS ARE LISTED IN THE PRODUCT INSTRUCTION FOR USE (IFU). (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER, (BEC) A LEAK AT THE PROBE WIPE BLOCK OF THE COULTER LH 500 HEMATOLOGY ANALYZER. THE VOLUME OF THE FLUID WAS A FEW DROPS AND WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE MATERIAL SAFETY DATA SHEET (MSDS) WAS REVIEWED BY THE CUSTOMER. THERE IS AN EXPOSURE CONTROL PLAN AT THE FACILITY. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE), INCLUDING A LABORATORY COAT AND GLOVES AT THE TIME OF THE EVENT. NO ONE WAS SPLASHED, SPRAYED OR INJURED. THERE WAS NO CONTACT TO OPEN OR BROKEN SKIN OR MUCOUS MEMBRANES. NO ONE SOUGHT MEDICAL ATTENTION. NO ERRONEOUS RESULTS WERE GENERATED IN CONNECTION TO THIS EVENT. THERE WAS NO DEATH, INJURY OR EFFECT TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133856 COULTER® LH 500 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER LH 500 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1