BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTLER LH750 HEMATOLOGY ANALYZER

    MDR report key: 2251220 · Received September 9, 2011

    Report

    Report Number
    1061932-2011-01377
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    October 20, 2009
    Report Date
    November 6, 2009
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061571
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED FOR THE PERIOD BETWEEN JANUARY 1, 2008 AND OCTOBER 23, 2010 OF COMPLAINTS FOR ADD'L REPORTABLE EVENTS. THE RAW DATA FORWARDED BY THE CUSTOMER FOR ANALYSIS DID NOT MATCH THE SPECIMEN IDENTIFICATION RECORDS DESCRIBED IN THE COMPLAINT. THE ROOT CAUSE FOR THIS EVENT WAS UNK. FIELD SERVICE WAS NOT DISPATCHED TO THE SITE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE LH750 HEMATOLOGY ANALYZER GENERATED ERRONEOUSLY LOW WBC (WHITE BLOOD CELL) RESULTS (19.5 X 10^3) ON ONE PT. THE TEST RESULTS WERE ACCOMPANIED BY INSTRUMENT-GENERATED MESSAGES FOR BLAST CELLS. THE SAMPLE WAS RETESTED ON THE LH750 ANALYZER AND THE WBC RESULTS WERE HIGHER (34.1 X 10^3). THE ERRONEOUS TEST RESULTS WERE NOT REPORTED OUT OF THE LAB. THERE WERE NO REPORTED CHANGES TO PT TREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK