BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750

    MDR report key: 1937052 · Received December 23, 2010

    Report

    Report Number
    1061932-2010-00309
    Event Type
    Malfunction
    Date Received
    December 23, 2010
    Date of Event
    November 24, 2010
    Report Date
    November 24, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLES WERE COLLECTED IN VACUTAINER TUBES AND STORED AT ROOM TEMPERATURE. QC WAS RUN BEFORE THE EVENT AND RECOVERED WITHIN ASSAY LIMITS. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND CLEANED FLOW LENS BLOCK, FLOW CELL AND LASER. THE FSE PERFORMED VCS CALIBRATION, COMPLETED GOOD START-UP, LATRON AND QC. THE FSE RAN PREVIOUS SAMPLES ELEVATED ON EOSINOPHILS AND CUSTOMER VERIFIED RESULTS WHICH WERE ACCEPTABLE. A CLEAR ROOT CAUSE HAS NOT BEEN DETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING ERRONEOUSLY HIGH EOSINOPHIL (EO) DIFFERENTIAL RESULTS GENERATED BY THE COULTER LH 750 ANALYZER FOR SEVERAL PATIENTS WITH NO INSTRUMENT GENERATED FLAGS. NO ERRONEOUS RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THERE WAS NO DEATH OR SERIOUS INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® LH 750 HEMATOLOGY ANALYZER GKZ BECKMAN COULTER, INC. LH 750

    Patients

    Seq Age Sex Outcome Treatment
    1