BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 750 HEMATOLOGY ANALYZER

    MDR report key: 4212160 · Received October 29, 2014

    Report

    Report Number
    1061932-2014-02669
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    October 2, 2014
    Report Date
    October 2, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K061574
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FSE FOUND THE HGB CHAMBER DRAINED PARTIALLY AND CAUSING INCOMPLETE HGB RESULTS. THE FSE REPLACED HGB BLANK VALVE, HGB CUVETTE AND ACTUATORS TO VL4, VL12, AND VL6. THE FSE ALSO REPLACED TUBING ASSOCIATED WITH THE REPLACED COMPONENTS. THE SERVICE WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES AND MEET THE PUBLISHED PERFORMANCE SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN UNCONTAINED FLUID LEAK OF APPROXIMATELY THREE (3) ML IN THE BACK OF THE COULTER LH 750 HEMATOLOGY ANALYZER. THE INSTRUMENT VOTED OUT (NO RESULTS GENERATED) HEMOGLOBIN (HGB) RESULTS ON PATIENT SAMPLES. THERE WAS NO REPORT OF INJURIES, ERRONEOUS RESULTS, DIRECT PHYSICAL CONTACT WITH THE LEAK OR CHANGE TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF GLOVES, GOGGLES, AND LABORATORY GOWN WHEN THE LEAK WAS OBSERVED. A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO EVALUATE THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692002 COULTER LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1