BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 750 HEMATOLOGY ANALYZER

    MDR report key: 4223177 · Received November 4, 2014

    Report

    Report Number
    1061932-2014-02740
    Event Type
    Malfunction
    Date Received
    November 4, 2014
    Date of Event
    October 16, 2014
    Report Date
    October 16, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2014, A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) EVALUATED THE ANALYZER AND REPAIRED THE LEAK. UPON VERIFICATION, THE FSE FOUND THAT THE INSTRUMENT LASER WAS MISALIGNED. THE LEAK HAD DAMAGED THE TRIPLE TRANSDUCER MODULE (TTM) AND CAUSED THE LASER TO MISALIGN. THE FSE REPLACED THE TRIPLE TRANSDUCER MODULE AND THE INSTRUMENT RAN WITHOUT ANY ERRORS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A LEAK WHEN USING THE COULTER LH 750 HEMATOLOGY ANALYZER. THE CUSTOMER DESCRIBED THE LEAK AS APPROXIMATELY 10 CC OF DILUENT, CONTAINED IN THE INSTRUMENT AND FROM THE AREA OF THE FLOW CELL. THE LEAK WAS IDENTIFIED DURING INSTRUMENT STARTUP. NO SAMPLES WERE RUN WHEN THE LEAK WAS IDENTIFIED, NO AFFECT TO PATIENT RESULTS OR TREATMENT. NO ERROR MESSAGES GENERATED BY THE INSTRUMENT, AND NO ELECTRICAL/OPTICAL ISSUES SEEN. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER'S FACILITY TO EVALUATE THE ANALYZER. THE FSE DETERMINED THAT THE LEAK CAUSED DAMAGE TO THE TRIPLE TRANSDUCER MODULE (TTM) AND CAUSED THE LASER TO MISALIGN. THE OPERATOR WAS WEARING GLOVES AND A LAB COAT WHEN THE LEAK WAS DISCOVERED. THERE WAS NO BIOHAZARD EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES. THERE WAS NO REPORT OF ERRONEOUS TEST RESULTS ASSOCIATED WITH THIS EVENT. THERE WAS NO DEATH, INJURY OR AFFECT TO USER OR PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705631 COULTER LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1