BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH750 HEMATOLOGY ANALYZER

    MDR report key: 2001943 · Received February 27, 2011

    Report

    Report Number
    1061932-2011-00093
    Event Type
    Malfunction
    Date Received
    February 27, 2011
    Date of Event
    January 28, 2011
    Report Date
    January 28, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONTROLS RUN BEFORE AND AFTER THE EVENT WERE WITHIN LIMITS. A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE AND IDENTIFIED THE PROBLEM AS AN AIR GAP AND BUBBLES IN DISPENSER. FSE REPLACED THE DISPENSER, CLEANED ALL SHEAR VALVES AND COMPLETED PREVENTIVE MAINTENANCE (PM) ON THE INSTRUMENT. FSE VERIFIED REPAIR PER ESTABLISHED PROCEDURES AND RAN SEVERAL SPECIMENS WHICH WHEN COMPARED WITH AN ALTERNATE INSTRUMENT WERE IDENTICAL. THE ROOT CAUSE IS ATTRIBUTED TO A DEFECTIVE RBC DILUENT DISPENSER.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING INTERMITTENT HIGH RBC AND PLATELET (PLT) RESULTS ON THE INITIAL SAMPLE RUN GENERATED BY THE COULTER LH750 HEMATOLOGY ANALYZER. THERE WAS NO DEATH, INJURY OR CHANGE TO PATIENT TREATMENT WITH REGARD TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® LH750 HEMATOLOGY ANALYZER AUTOMATED DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1