BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 3203153 · Received July 2, 2013

    Report

    Report Number
    1061932-2013-01362
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 4, 2013
    Report Date
    June 4, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) OBSERVED THE FLUID LEAK ORIGINATED FROM THE FITTING ON THE DILUTER FOR THE COMPLETE BLOOD COUNT (CBC) LYSE RESTRICTOR TUBING. THE FSE REPLACED THE CBC LYSE RESTRICTOR TUBING AND RESOLVED THE ISSUES. SERVICE ACTIVITY PERFORMED WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS AND WAS RETURNED TO NORMAL OPERATION. THIS MEDWATCH REPORT IS RELATED TO MDR 1061932-2013-01361.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED SLIGHTLY ELEVATED HEMOGLOBIN (HGB) RESULTS, WITHIN THE REFERENCE RANGE, FOR SEVERAL PATIENTS, ON SEPARATE DAYS, INVOLVING THE COULTER LH 750 HEMATOLOGY ANALYZER. THE CUSTOMER REANALYZED THE PATIENT SAMPLES ON AN ALTERNATE INSTRUMENT AND OBTAINED LOWER RESULTS. THE CUSTOMER OPENED THE FRONT COVER OF THE ORIGINAL INSTRUMENT AND DISCOVERED APPROXIMATELY TWO MILLILITERS OF FLUID LEAKED AND CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES AND A LABORATORY COAT AND DID NOT HAVE DIRECT CONTACT WITH THE FLUID. THERE WAS NO OPERATOR INJURY OR ADVERSE EFFECT ASSOCIATED WITH THIS EVENT. THE ELEVATED RESULTS WERE RELEASED OUT OF THE LABORATORY. THERE HAS BEEN NO REPORT OF PATIENT CONSEQUENCE OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. THE FACILITY HAS AN EXPOSURE CONTROL OR RISK MANAGEMENT PLAN IN PLACE. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT. THIS IS REPORT TWO OF TWO REFERENCING THE EVENT DATE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301489 COULTER® LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1