BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER GEN-S SYSTEM

    MDR report key: 2183640 · Received July 8, 2011

    Report

    Report Number
    1061932-2011-00821
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    April 27, 2008
    Report Date
    April 27, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKL
    PMA / PMN Number
    K962988
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE UNIT WAS PERFORMING WITHIN QUALITY CONTROL SPECS AND THE CONTROLS RUN BEFORE THE INCIDENT RECOVERED WITHIN EXPECTED RANGE. SAMPLES WERE RERUN BACK TO THE LAST ACCEPTABLE RUN TO CONFIRM ACCURATE. INSTRUMENT SENSITIVITY SETTING IS SET AT [22222] MID LEVELS FOR ALL PARAMETERS. RAW DATA WAS NOT AVAILABLE FOR THESE PTS. SERVICE WAS NOT DISPATCHED FOR THIS EVENT. ROOT CAUSE IS UNK, RAW DATA WAS NOT AVAILABLE FOR THESE PT RESULTS. THE ANALYZER PRODUCED INSTRUMENT GENERATED MESSAGES FOR THE DIFFERENTIAL PARAMETER ALERTING THE OPERATOR TO FURTHER REVIEW THE SAMPLES. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN 01/01/2008 AND 10/23/2010 OF COMPLAINTS FOR ADD'L REPORTABLE EVENTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ERRONEOUS DIFFERENTIAL RESULTS FOR TWO PT SAMPLES WERE OBTAINED WHEN USING A COULTER GEN-S SYSTEM. ERRONEOUS TEST RESULTS WERE LOW NEUTROPHIL % AND HIGH LYMPHOCYTE % WITH INSTRUMENT GENERATED FLAGS FOR DIFFERENTIAL PARAMETERS. MANUAL DIFFERENTIALS WERE PERFORMED WITH BLOOD SMEARS FOR BOTH SAMPLES DUE TO THE INSTRUMENT GENERATED FLAGS. BOTH SAMPLES WERE THEN RETESTED WITH THE SAME ANALYZER. CORRECT RESULTS WERE OBTAINED. TEST RESULTS FOR ONE OF THE TWO PTS WERE REPORTED OUT OF THE LABORATORY. 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 GEN-S SYSTEM GKL BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1