BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH750

    MDR report key: 2193464 · Received May 10, 2011

    Report

    Report Number
    1061932-2011-00392
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    January 19, 2009
    Report Date
    January 23, 2009
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061574
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED FOR THE PERIOD BETWEEN JANUARY 1, 2008 - OCTOBER 23, 2010 OF COMPLAINTS FOR ADD'L REPORTABLE EVENTS. THIS REPORT IS DAY 1 OF 2. SEE MDR # 1061932-2011-00393 FOR DAY 2 OF 2. ON (B)(4) 2009, THE INSTRUMENT WAS SERVICED BY A FIELD SERVICE ENGINEER FOR AN UNRELATED ISSUE. THE INSTRUMENT PERFORMANCE WAS VERIFIED. THE ROOT CAUSE AS DETERMINED BY RAW DATA ANALYSIS APPEARS TO BE THAT THE USER CHOSE A FLAGGING OPTION ON THE INSTRUMENT'S COMPUTER FOR DIFFERENTIAL ALGORITHM THAT WAS NOT SENSITIVE ENOUGH TO CATCH THE ABNORMALITY AS PRESENTED IN THIS PT'S SAMPLE.

    Description of Event or Problem · 1

    ON (B)(6) 2009, THE LH750 HEMATOLOGY ANALYZER GENERATED ERRONEOUS DIFFERENTIAL RESULTS ON ONE PT WHEN COMPARED TO MANUAL DIFFERENTIAL RESULTS. TWENTY-ONE BLAST CELLS (IMMATURE WHITE BLOOD CELLS) WERE OBSERVED WITH THE MANUAL DIFFERENTIAL; HOWEVER, THERE WERE NONE ON THE AUTOMATED DIFFERENTIAL NOR WERE THERE ANY INSTRUMENT-GENERATED BLAST FLAGS WITH THE RESULTS FROM THE LH750 ANALYZER. THE ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE OF THE LAB. THERE WERE NO REPORTED CHANGES TO PT TREATMENT ASSOCIATED WITH THE INCORRECT RESULT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA