BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 500 HEMATOLOGY ANALYZER

    MDR report key: 2159403 · Received July 12, 2011

    Report

    Report Number
    1061932-2011-00864
    Event Type
    Malfunction
    Date Received
    July 12, 2011
    Date of Event
    June 11, 2011
    Report Date
    June 11, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K032000
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS PROVIDED AND THE FIELD SERVICE ENGINEER (FSE) INDICATED FINDING A CRACKED SENSOR. THIS SENSOR IS LOCATED IN THE BACK-TOP LEFT SIDE OF THE INSTRUMENT AND IS UTILIZED TO DETECT CLENZ. THE SENSOR COULD NOT DETECT THE PRESENCE OF CLENZ IN ITS PATHWAY. AS A RESULT, THERE WAS A CLENZ LEAK OF APPROXIMATELY 4 ML. THE SENSOR WAS REPLACED. REPAIRS PER ESTABLISHED PROCEDURES WERE VERIFIED AND RESULTS MET PUBLISHED PERFORMANCE SPECIFICATIONS. THE SPILL WAS CLEANED UP ACCORDING TO THE DEFINED LABORATORY PROTOCOL. ROOT CAUSE FOR THE LEAK WAS ASSOCIATED WITH A CRACKED CLENZ SENSOR.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) A REAGENT LEAK AT THE BACK OF COULTER LH 500 HEMATOLOGY ANALYZER WHERE THE CLENZ LINE CONNECTS TO ITS FITTING. IN ADDITION, THE INSTRUMENT WAS INDICATING CLENZ OUT ERROR ALERTS. THE CUSTOMER STATED THAT THERE WAS NO BLOOD LEAKING, BUT THE SOURCE OF THE LEAK COULD NOT BE IDENTIFIED BY THE CUSTOMER. THE USER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GOWN, GLOVES AND GLASSES AT THE TIME OF THE INCIDENT. THE MATERIAL SAFETY DATA SHEET (MSDS) WAS NOT REVIEWED; HOWEVER, IT IS READILY AVAILABLE. NO INJURIES OCCURRED AND MEDICAL ATTENTION WAS NOT SOUGHT. THERE WAS NO REPORT OF EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. THE LAB'S EXPOSURE CONTROL OR RISK MANAGEMENT PLANS ARE IN PLACE. THERE WAS NO DEATH, INJURY OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR ASSOCIATED TO THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® LH 500 HEMATOLOGY ANALYZER DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER, INC. LH 500 NA

    Patients

    Seq Age Sex Outcome Treatment
    1