BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 780 HEMATOLOGY ANALYZER

    MDR report key: 1911188 · Received November 30, 2010

    Report

    Report Number
    1061932-2010-00231
    Event Type
    Malfunction
    Date Received
    November 30, 2010
    Date of Event
    October 29, 2010
    Report Date
    November 1, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061616
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLES WERE COLLECTED IN 5ML VACUTAINER TUBES STORED AT ROOM TEMPERATURE AND SAMPLED WITHIN LESS THAN 2 HOURS IN THE MANUAL MODE. CONTROLS WERE RUN BEFORE AND AFTER THE EVENT AND THE CONTROL RESULTS WERE WITHIN ASSAY LIMITS. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(6) 2010 FOR THIS EVENT. THE FSE REPLACED SOME HARDWARE AND PERFORMED REPAIRS. THE ROOT CAUSE IS UNKNOWN. HOWEVER, THE SYSTEM PROVIDED INSTRUMENT MESSAGES TO ALERT THE OPERATOR TO REVIEW THE SAMPLE RESULTS. PER LABELING, BECKMAN COULTER INC. SUGGESTS USING ALL AVAILABLE FLAGGING OPTIONS TO OPTIMIZE THE SENSITIVITY OF INSTRUMENT RESULTS BASED ON THE PATIENT POPULATION.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) THAT THE COULTER LH 780 HEMATOLOGY ANALYZER GENERATED ERRONEOUS NUCLEATED RED BLOOD CELL (NRBC) RESULTS FOR THREE PATIENT SAMPLES ON DIFFERENT DAYS ((B)(6) 2010). A MANUAL SMEAR REVIEW WAS PROMPTED BASED ON DECISION RULES. THE MANUAL SMEAR REVEALED NRBCS WHICH DIFFERED FROM THE ORIGINAL RESULTS OBTAINED FROM THE INSTRUMENT. NO ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. THERE WAS NO DEATH, SERIOUS INJURY, OR CHANGE TO PATIENT TREATMENT DURING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® LH 780 HEMATOLOGY ANALYZER HEMATOLOGY ANALYZER GKZ BECKMAN COULTER, INC. LH 780 NA

    Patients

    Seq Age Sex Outcome Treatment
    1