BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 750 HEMATOLOGY ANALYZER

    MDR report key: 4223176 · Received November 4, 2014

    Report

    Report Number
    1061932-2014-02727
    Event Type
    Malfunction
    Date Received
    November 4, 2014
    Date of Event
    October 7, 2014
    Report Date
    October 7, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON 10/08/2014, A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) EVALUATED THE ANALYZER AND FOUND THE RED BLOOD CELL (RBC) RESULTS WERE ELEVATED FOR THE QUALITY CONTROL SAMPLES, AND THE STARTUP HAD FAILED FOR RBC AND PLATELET PARAMETERS. THE RBC DISPENSER WAS DEFECTIVE AND WAS REPLACED. THE INSTRUMENT PASSED STARTUP AND ALL CONTROLS. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED ELEVATED RED BLOOD CELL (RBC) TEST RESULTS WERE OBTAINED FOR THE QUALITY CONTROL SAMPLES WHEN USING THE COULTER LH 750 HEMATOLOGY ANALYZER. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER'S FACILITY TO EVALUATE THE ANALYZER. THERE WAS NO IMPACT TO PATIENT RESULTS, AS PATIENT SAMPLES WERE NOT TESTED ON THE ANALYZER. THERE WAS NO DEATH, INJURY OR AFFECT TO USER OR PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705410 COULTER LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1