BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 1907796 · Received November 24, 2010

    Report

    Report Number
    1061932-2010-00226
    Event Type
    Malfunction
    Date Received
    November 24, 2010
    Date of Event
    October 27, 2010
    Report Date
    October 27, 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
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC WAS WITHIN THE ESTABLISHED RANGES WITH RESPECT TO ACCURACY AND PRECISION. THE RAW DATA ANALYSIS REVEALED THE NRBC AND LYMPH POPULATIONS WERE COMPLETELY MIXED IN THE WBC HISTOGRAM. DEBRIS PATTERN IN THE DIFF SCATTER PLOT DOES NOT SUGGEST NRBC. A BCI FIELD SERVICE ENGINEER (FSE) COULD NOT FIND ANY INSTRUMENT ISSUES AND VERIFIED THE INSTRUMENT OPERATION. THE INSTRUMENT GENERATED AN IMM. NE2 AND IMM. NE1 ON RE-RUN OF THE SPECIMEN, WHICH ALERTS THE OPERATOR TO FURTHER REVIEW THE SPECIMEN. 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. THE 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 ERRONEOUSLY LOW NRBC RESULTS GENERATED BY COULTER LH750 HEMATOLOGY ANALYZER THAT DID NOT FLAG FOR ONE PATIENT SAMPLE. THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. A MANUAL DIFFERENTIAL WAS PERFORMED AND 45% NRBC CELLS WERE SEEN. REPEAT TEST ON LH750 ANALYZER GENERATED 20% NRBC WITH IMM. NE2 AND IMM. NE1 FLAGS. MANUAL DIFFERENTIAL RESULTS WERE REPORTED OUT AND RECOVERED IMMATURE CELL TYPES. THERE WAS NO CHANGE TO PATIENT TREATMENT. NO DEATH OR SERIOUS INJURY IS ASSOCIATED WITH THIS EVENT.

    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