BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2183630 · Received July 8, 2011

    Report

    Report Number
    1061932-2011-00820
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    April 22, 2008
    Report Date
    April 25, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061574
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS WITHIN QC SPECIFICATIONS WITH RESPECT TO CONTROLS AND REPRODUCIBILITY. CONTROLS WERE RUN ONCE PER SHIFT. CONTROLS WERE RUN BEFORE AND AFTER THIS INCIDENT. ON (B)(4) 2008, THE FIELD SERVICE ENGINEER EVALUATED THE ANALYZER AND VERIFIED THE INSTRUMENTS PERFORMANCE. RAW DATA ANALYSIS WAS CONDUCTED. ROOT CAUSE BASED ON RAW DATA ANALYSIS IS THAT THE SAMPLE SHOWS A LYMPHOCYTE DOMINANT PATTERN WITH MUCH SMALLER. NEUTROPHIL AND MONOCYTE POPULATIONS. BLAST FLAGS ARE BASED ON THE ABNORMAL PATTERNS OF NEUTROPHIL OR MONOCYTE POPULATIONS. THE ALGORITHM ALSO CHECKED FOR ABNORMALITY OF THE LYMPHOCYTE POPULATION AND GENERATED A VARIANT LYMPH FLAG FOR THE FIRST RERUN OF THE PATIENT SAMPLE. THE STATISTICS OF THE LYMPHOCYTE POPULATION WERE WITHIN NORMAL RANGE. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN (B)(4) 2008 AND (B)(4), 2010 OF COMPLAINTS FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ERRONEOUS DIFFERENTIAL RESULTS WERE OBTAINED WHEN USING THE COULTER LH 750 HEMATOLOGY ANALYZER. THE TEST RESULTS WERE NOT ACCOMPANIED BY INSTRUMENT GENERATED FLAGS. THE TEST RESULTS WERE DETERMINED TO BE ERRONEOUS BASED ON COMPARISON TO A MANUAL BLOOD SMEAR DIFFERENTIAL, WHICH CONTAINED BLAST CELLS. ERRONEOUS TEST RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. NO REPORTS OF DEATH OR SERIOUS INJURY, AND NO AFFECT TO PATIENT TREATMENT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER LH 750 HEMATOLOGY ANALYZER GKZ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK