BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH750 HEMATOLOGY ANALYZER

    MDR report key: 2180986 · Received July 1, 2011

    Report

    Report Number
    1061932-2011-00691
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    April 29, 2009
    Report Date
    April 30, 2009
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061574
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED FOR THE PERIOD BETWEEN (B)(4) 2008 AND (B)(4) 2010 OF COMPLAINTS FOR ADDITIONAL REPORTABLE EVENTS. THIS MDR IS FOR DAY 4 OF 5 FOR ANALYZER 1 OF 2. OTHER EVENTS IN THIS SERIES: MDR #1061932-2011-00688, DAY 1 OF 5 FOR ANALYZER 1 OF 2. 1061932-2011-00689, DAY 2 OF 5 FOR ANALYZER 2 OF 2. MDR #1061932-2011-00690, DAY 3 OF 5 FOR ANALYZER 2 OF 2. MDR #1061932-2011-00692, DAY 5 OF 5 FOR ANALYZER 1 OF 2. ANALYSIS OF THE RAW TEST DATA FOR THIS PT SAMPLE SHOWED AN ABNORMAL PATTERN WITH DOMINANT BLAST CELL POPULATION LOCATED IN THE MONOCYTE-NEUTROPHIL REGION. THE SOFTWARE ALGORITHM IN THE LH750 ANALYZER WAS NOT SENSITIVE ENOUGH TO DISTINGUISH THESE CELLS AS BLASTS, THUS A FLAG FOR BLAST CELLS WAS NOT TRIGGERED. THIS APPEARED TO BE A SAMPLE-SPECIFIC ISSUE AND FIELD SERVICE WAS NOT DISPATCHED TO THE SITE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE LH750 HEMATOLOGY ANALYZER FAILED TO FLAG FOR THE PRESENCE OF BLAST CELLS IN ONE PT SAMPLE. THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE RESULTS WERE EITHER QUESTIONED BY THE TREATING PHYSICIAN OR REVIEWED BECAUSE OF OTHER ABNORMAL RESULTS. A MANUAL DIFFERENTIAL WAS PERFORMED AND 89% BLAST CELLS WERE OBSERVED. THE CUSTOMER BELIEVED THIS TO BE THE CORRECT RESULT. THERE WERE NO REPORTED CHANGES TO PT TREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER LH750 HEMATOLOGY ANALYZER GKZ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK