BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2211585 · Received August 5, 2011

    Report

    Report Number
    1061932-2011-01081
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    March 5, 2010
    Report Date
    March 5, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061574
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PT WAS DRAWN IN A 4ML VACUTAINER TUBE. THE SAMPLE WAS AN ESTIMATED VOLUME OF 2ML (SHORT SAMPLE). CONTROLS WERE RUN BEFORE AND AFTER THIS EVENT AND WERE WITHIN ACCEPTABLE RANGES. SERVICE WAS NOT DISPATCHED FOR THIS INCIDENT. ROOT CAUSE FOR THE ERRONEOUS WBC IS UNK. THE ALGORITHM FUNCTIONED AS DESIGNED. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN (B)(4) 2008 AND (B)(4) 2010 OF COMPLAINTS FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ERRONEOUS HIGH WHITE BLOOD CELL (WBC) RESULTS WERE OBTAINED FOR ONE PT SAMPLE WHEN USING THE COULTER LH 750 HEMATOLOGY ANALYZER. THERE WERE NO INSTRUMENT GENERATED FLAGS WITH THE TEST RESULT. ERRONEOUS TEST RESULTS WERE REPORTED OUT OF THE LAB. THE PHYSICIAN QUESTIONED THE RESULTS. A MANUAL DIFFERENTIAL WAS PERFORMED AND NO WHITE BLOOD CELLS WERE SEEN ON THE BLOOD SMEAR SLIDE. THE SAMPLE WAS RETESTED ON THE COULTER GEN-S SYSTEM. THE INITIAL TEST RESULTS WERE DETERMINED TO BE ERRONEOUS BASED ON THE BLOOD SMEAR AND RETEST RESULTS. A CORRECTED REPORT WAS ISSUED. NO REPORTS OF DEATH OR SERIOUS INJURY, AND NO AFFECT TO PT TREATMENT AS A RESULT OF THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK