BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 500 HEMATOLOGY ANALYZER

    MDR report key: 1945122 · Received January 3, 2011

    Report

    Report Number
    1061932-2010-00319
    Event Type
    Malfunction
    Date Received
    January 3, 2011
    Date of Event
    September 19, 2010
    Report Date
    September 19, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K032000
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLES WERE COLLECTED IN 4 ML EDTA TUBES. THE SAMPLES WERE STORED AT ROOM TEMPERATURE AND PROCESSED WITHIN AN HOUR OF COLLECTION. CONTROLS WERE RUN BEFORE AND AFTER THE EVENT AND RECOVERED WITHIN ASSAY LIMITS. THE CUSTOMER BLEACHED THE FLOWCELL, BUT IT DID NOT RESOLVE THE BASOPHILIA. A BCI FIELD SERVICE ENGINEER (FSE) VISITED THE SITE ON (B)(4) 2010. THE FSE REPLACED THE CAM PLATE FOR THE ROCKER BED. THE FSE CLEANED OUTSIDE OF FLOW CELL AND SCATTER SENSOR. THE FSE VERIFIED THE SYSTEM OPERATION. A DEFINITIVE ROOT CAUSE FOR THE EVENT HAS NOT BEEN DETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUSLY HIGH BASOPHIL RESULTS GENERATED BY COULTER LH500 HEMATOLOGY ANALYZER. THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THE MANUAL SMEAR RESULTS SHOWED NO ABNORMALITIES. THERE WAS NO DEATH, INJURY, OR EFFECT TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® LH 500 HEMATOLOGY ANALYZER HEMATOLOGY ANALYZER GKZ BECKMAN COULTER, INC. LH500 NA

    Patients

    Seq Age Sex Outcome Treatment
    1