BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH500 HEMATOLOGY ANALYZER

    MDR report key: 3011065 · Received March 19, 2013

    Report

    Report Number
    1061932-2013-00406
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    February 20, 2013
    Report Date
    February 20, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K042724
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THE COULTER LH500 HEMATOLOGY ANALYZER LEAKED APPROXIMATELY A QUART OF FLUID FROM THE RIGHT SIDE OF THE INSTRUMENT ONTO THE COUNTERTOP AND FLOOR. THE CUSTOMER STATED THAT THE ANALYZER GAVE DILUENT COMPARISON OUT OF LIMITS ERRORS, ALERTING THE OPERATOR TO AN INSTRUMENT PROBLEM. THE CUSTOMER WAS WEARING A LAB COAT, GOGGLES AND GLOVES AT THE TIME OF THE OCCURRENCE. THERE WAS NO REPORT OF INJURY OR EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES, AND MEDICAL ATTENTION WAS NOT SOUGHT. THE CUSTOMER REVIEWED THE MATERIAL SAFETY DATA SHEET (MSDS) AND THE FACILITY HAS AN EXPOSURE CONTROL PLAN IN PLACE. THE CUSTOMER STATED THAT NO PATIENT RESULTS HAD BEEN AFFECTED. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) FOUND THAT THE TUBING AT PINCH VALVE 47 WAS LEAKING AND NOT ALLOWING DILUENT TO THE BLOOD SAMPLING VALVE (BSV). THE FSE REPLACED THE TUBING, WHICH FIXED THE LEAK AND CORRECTED THE DILUENT COMPARISON OUT OF LIMITS ISSUE. THE FSE VERIFIED THE REPAIR PER ESTABLISHED PROCEDURES, AND THE RESULTS MET THE PUBLISHED PERFORMANCE SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113987 COULTER® LH500 HEMATOLOGY ANALYZER DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER LH500 NA

    Patients

    Seq Age Sex Outcome Treatment
    1