BEUDAMED
    FDA Adverse Event Summary report: N

    COULTER® LH 780

    MDR report key: 1972882 · Received January 28, 2011

    Report

    Report Number
    1061932-2011-00049
    Date Received
    January 28, 2011
    Date of Event
    December 29, 2010
    Report Date
    December 30, 2010
    Manufacturer
    BECKMAN COULTER INC
    Product Code
    GKZ
    PMA / PMN Number
    K061616
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WERE COLLECTED IN A VACUTAINER PURPLE TOP SAMPLE TUBE AND STORED AT ROOM TEMPERATURE. THE SAMPLES WERE RERUN TO CONFIRM ACCURACY BACK TO THE LAST ACCEPTABLE CONTROL RUN. CONTROLS WERE RUN BEFORE AND AFTER THE INCIDENT. RESULTS WERE WITHIN ASSAY RANGES. THE INSTRUMENT IS CURRENTLY WITHIN QC SPECIFICATIONS WITH RESPECT TO CONTROLS (ACCURACY) AND REPRODUCIBILITY (PRECISION). A BCI FIELD SERVICE ENGINEER (FSE) REPLACED A LEAKING RBC AND WBC DISPENSERS. RAN SEVERAL SAMPLES AND SUCCESSFULLY COMPLETED VERIFICATION WITHOUT ISSUES. LEAKING DISPENSERS ARE THE ROOT CAUSE OF THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS ERRONEOUS HIGH RBC AND HCT RESULTS GENERATED BY THE COULTER LH 780 HEMATOLOGY ANALYZER. IN ADDITION, A REVIEW OF THE DATA SHOWED THAT THE MCH, MCHC RESULTS WERE LOW AND PLATELETS (PLT) PARAMETER RESULTS WERE HIGH. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. THE SAMPLES WERE REPEATED AND LOWER RESULTS FOR RBC, HCT, MCH, AND MCHC WERE OBTAINED. AMENDED REPORTS WERE INITIATED ON THE DATE OF THE EVENT. NO CHANGE TO PATIENT TREATMENT, NO DEATH OR SERIOUS INJURY IS ASSOCIATED WITH THIS EVENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® LH 780 HEMATOLOGY ANALYZER GKZ BECKMAN COULTER INC LH 780 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1