BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LH 500 HEMATOLOGY ANALYZER

    MDR report key: 4183024 · Received October 17, 2014

    Report

    Report Number
    1061932-2014-02536
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 19, 2014
    Report Date
    September 19, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K042724
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) FOUND THE SWEEP FLOW RESTRICTOR TUBING HAD DISCONNECTED AND LEAKED ONTO THE CBC MODULE MANIFOLD (MF1) AND WIRE HARNESS CAUSING THE MANIFOLD TO NOT FUNCTION PROPERLY. THE FSE REPLACED THE CBC MANIFOLD AND WIRE HARNESS AND RECONNECTED THE SWEEP FLOW TUBING TO RESOLVE THIS ISSUE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE WHITE BLOOD COUNT (WBC) AND RED BLOOD COUNT (RBC) PLATELET (PLT) BACKGROUND FAILING ON THE LH 500 HEMATOLOGY ANALYZER. THE INSTRUMENT OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF A LABORATORY COAT, GLOVES, AND EYE PROTECTION DURING THE EVENT. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER'S FACILITY TO EVALUATE THE ANALYZER. THERE WERE NO ERRONEOUS TEST RESULTS ASSOCIATED WITH THIS EVENT. THERE WAS NO DEATH, INJURY OR AFFECT TO THE USER OR PATIENT TREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661914 LH 500 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1