BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 780 HEMATOLOGY ANALYZER

    MDR report key: 2291031 · Received October 13, 2011

    Report

    Report Number
    1061932-2011-01757
    Event Type
    Malfunction
    Date Received
    October 13, 2011
    Date of Event
    September 8, 2011
    Report Date
    September 12, 2011
    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
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE INFORMATION WAS NOT PROVIDED BY THE CUSTOMER. THE ROOT CAUSE FOR THE ERRONEOUS DIFFERENTIALS (HIGH EO / LOW NE) IS THAT THE SAMPLES SHOW ABNORMAL NEUTROPHIL POPULATIONS ON THE HISTOGRAMS. HOWEVER, THE INSTRUMENT GENERATED MESSAGES TO ALERT THE OPERATOR TO REVIEW THE RESULTS. SERVICE WAS NOT DISPATCHED FOR THIS EVENT. PER LABELING, FLAGS, CODES, SUSPECT AND DEFINITIVE MESSAGES ARE USED TO ALERT YOU TO AN INSTRUMENT MALFUNCTION, SPECIMEN ABNORMALITY, ABNORMAL DATA PATTERN, OR ABNORMAL RESULTS. BECKMAN COULTER RECOMMENDS REVIEW, APPROPRIATE TO YOUR PATIENT POPULATION, OF ALL RESULTS DISPLAYING A FLAG, CODE OR OTHER MESSAGE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) STATING THAT THE COULTER LH 780 HEMATOLOGY ANALYZER GENERATED ERRONEOUSLY HIGH EOSINOPHIL (EO) AND LOW NEUTROPHIL (NE) RESULTS WITH INSTRUMENT GENERATED MESSAGES. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. THE MANUAL DIFFERENTIAL RESULTS AND SAMPLE RERUN SHOWED LOWER EO% (0.0) AND HIGHER NE% RESULTS. THE EO AND NE RESULTS PROVIDED BY THE CUSTOMER ARE SHOWN. THERE WAS NO DEATH, INJURY OR CHANGE TO PATIENT TREATMENT AS A RESULT OF THIS INCIDENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1