BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH500

    MDR report key: 2080313 · Received May 6, 2011

    Report

    Report Number
    1061932-2011-00350
    Event Type
    Malfunction
    Date Received
    May 6, 2011
    Date of Event
    April 8, 2011
    Report Date
    April 8, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K032000
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SPECIMEN WAS COLLECTED IN A 3ML, BD TUBE. QC WAS WITHIN ASSAY RANGE BEFORE AND AFTER THE EVENT. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED. THE FSE INSPECTED THE INSTRUMENT AND FOUND NO ISSUES. BASED ON RAW DATA, THE SAMPLE RUNS HAVE ABNORMAL CELLS SUCH AS BLASTS, NRBCS, METAMYELOCYTES AND MYELOCYTES. HOWEVER, THE HISTOGRAMS DO NOT SHOW SIGNIFICANTLY ABNORMAL PATTERNS. ALL POPULATIONS ARE TIGHT AND HAVE NORMAL SHAPE. THERE ARE A FEW EVENTS IN HIGH DC (VOLUME) REGION AND POPULATIONS ARE RELATIVELY CLOSE TO OTHERS, BUT THEY WERE NOT SEVERE ENOUGH TO TRIGGER SUSPECT FLAGS. THE ALGORITHM DID NOT SET SUSPECT FLAGS BECAUSE THE HISTOGRAMS DO NOT SHOW SIGNIFICANTLY ABNORMAL PATTERNS. ROOT CAUSE IS UNKNOWN FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC, (BCI) REPORTING THAT THE COULTER LH500 INSTRUMENT FAILED TO PROVIDE INSTRUMENT FLAGS FOR BLASTS, NRBCS AND OTHER IMMATURE CELLS FOR THE INITIAL SAMPLE RUN OF A PATIENT. A MANUAL SMEAR REVIEW CONFIRMED THE PRESENCE OF THESE CELLS. THE SAMPLE WAS REFRIGERATED AND REPEATED THE FOLLOWING DAY AND INSTRUMENT-GENERATED FLAGS AND SUSPECT MESSAGES WERE OBTAINED. NO ERRONEOUS RESULTS WERE REPORTED OUT OF THE LAB. THERE WAS NO DEATH OR INJURY. NO EFFECT TO PATIENT TREATMENT WAS ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER LH500 AUTOMATED DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER, INC. LH500, TN N/A

    Patients

    Seq Age Sex Outcome Treatment
    1