BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 750 HEMATOLOGY ANALYZER

    MDR report key: 4170238 · Received October 14, 2014

    Report

    Report Number
    1061932-2014-02592
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Date of Event
    September 22, 2014
    Report Date
    September 22, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, 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 REPLACED LV14B; IT WAS BROKEN AT THE BASE. THE FSE ALSO REPLACED VL 14A, IT WAS BROKEN ALSO. (B)(4).

    Description of Event or Problem · 1

    A BECKMAN COULTER FIELD SERVICE ENGINEER IDENTIFIED A BROKEN VALVE WHILE SERVICING A COULTER LH 750 HEMATOLOGY ANALYZER IN A CUSTOMER'S FACILITY ON (B)(4) 2014. 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
    649675 COULTER LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1