BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 1873153 · Received October 18, 2010

    Report

    Report Number
    1061932-2010-00183
    Event Type
    Malfunction
    Date Received
    October 18, 2010
    Date of Event
    September 15, 2010
    Report Date
    October 18, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC PRIOR TO AND AFTER THE EVENT WAS WITHIN THE ESTABLISHED RANGES. THE RAW DATA ANALYSIS REVEALED THE SAMPLE SHOWS ABNORMAL PATTERN IN THE SCATTER DIAGRAMS. THE NEUTROPHIL POPULATION OVERLAPS WITH BOTH THE LYMPHOCYTES AND MONOCYTES POPULATIONS. THE SPECIMEN WAS NOT SIGNIFICANTLY ABNORMAL TO TRIGGER A BLAST FLAG. BCI DOES NOT CLAIM TO IDENTIFY EVERY ABNORMALITY IN ALL SAMPLES. BCI SUGGESTS USING ALL AVAILABLE FLAGGING OPTIONS TO OPTIMIZE THE SENSITIVITY OF THE INSTRUMENT RESULTS. A BCI FIELD SERVICE ENGINEER (FSE) VERIFIED THE DIFF REAGENT PUMP VOLUMES, THE LYSE DILUENT TIMING AND THE DC NOISE WHILE RUNNING DILUENT REAGENT. THE LH750 INSTRUMENT'S OPERATION WAS VERIFIED. A DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO A BLAST RESULT GENERATED BY COULTER LH750 HEMATOLOGY ANALYZER THAT DID NOT FLAG FOR ONE PATIENT SAMPLE. THE ERRONEOUS RESULT WAS NOT REPORTED OUT OF THE LABORATORY. A MANUAL DIFFERENTIAL WAS PERFORMED AND 21% BLAST CELLS WERE SEEN. THE MANUAL DIFFERENTIAL RESULTS WERE REPORTED. THE SAME SPECIMEN WAS RERUN TWICE AND THE INSTRUMENT GENERATED A BLAST FLAG ON THE FIRST RERUN AND AN IMM. NE2 DIFFERENTIAL FLAG ON THE SECOND RERUN. THERE WAS NO DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. IMM. NE2 FLAG MEANS IMMATURE NEUTROPHIL 2. NOTE: THE LH 700 SERIES PROVIDES THE LABORATORY WITH THE ABILITY TO ADJUST THE SENSITIVITY OF DIFFERENTIAL SUSPECT MESSAGES (IMM NE 1, IMM NE 2, VARIANT LYMPHS, AND BLASTS) TO MEET INDIVIDUAL LABORATORY REQUIREMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® LH 750 HEMATOLOGY ANALYZER HEMATOLOGY ANALYZER GKZ BECKMAN COULTER, INC. LH750 NA

    Patients

    Seq Age Sex Outcome Treatment
    1