BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH750 HEMATOLOGY ANALYZER

    MDR report key: 2180983 · Received July 1, 2011

    Report

    Report Number
    1061932-2011-00688
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    March 3, 2009
    Report Date
    March 10, 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 1 OF 5 FOR ANALYZER 1 OF 2. OTHER EVENTS IN THIS SERIES: MDR #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 #1061932-2011-00691, DAY 4 OF 5 FOR ANALYZER 1 OF 2. MDR #1061932-2011-00692, DAY 5 OF 5 FOR ANALYZER 1 OF 2. PER THE CUSTOMER, THE PT SAMPLE WAS ORIGINALLY RUN AT 50% BLAST FLAG SENSITIVITY AND REPEATED AT AN INCREASED SENSITIVITY SETTING OF 75%; HOWEVER, BLAST CELLS REMAINED UNFLAGGED. RAW TEST DATA FROM THIS PT SAMPLE WERE NOT PROVIDED FOR ANALYSIS. THE ROOT CAUSE IS UNK. THIS APPEARS TO BE A SAMPLE-SPECIFIC ISSUE AND FIELD SERVICE WAS NOT DISPATCHED TO THE SITE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT 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 QUESTIONED BY THE TREATING PHYSICIAN AND A MANUAL DIFFERENTIAL WAS PERFORMED. LABORATORY PERSONNEL REPORTED SEEING 25% BLAST CELLS OF "MEDIUM SIZE." THE CUSTOMER BELIEVED THIS TO BE THE CORRECT RESULT. THE SAMPLE WAS REPEATED ON THE LH750 ANALYZER; HOWEVER, THE BLAST CELLS REMAIN UNFLAGGED. 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 23 YR