BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH750 HEMATOLOGY ANALYZER

    MDR report key: 2181001 · Received July 1, 2011

    Report

    Report Number
    1061932-2011-00676
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    August 1, 2009
    Report Date
    August 3, 2009
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061574
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE SITE TO INVESTIGATE THE EVENT. THE FSE REVIEWED THE APERTURE COUNTS AND THE INSTRUMENT'S HISTORY LOG. THE FSE CONCLUDED THE FIRST TWO APERTURES HAD PARTIAL PLUGS AND THE TWO APERTURES MATCHED WITH LOW WBC COUNTS. THE ROOT CAUSE FOR THIS EVENT IS THAT A PARTIAL PLUG CAUSED TWO APERTURES TO MATCH WITH AN ERRONEOUSLY LOW WBC RESULT. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN (B)(4) 2008 AND (B)(4) 2010 FOR ADD'L REPORTABLE EVENTS.

    Description of Event or Problem · 1

    THE LH750 INSTRUMENT GENERATED FALSE LOW WBC (WHITE BLOOD CELL) COUNT RESULT ON A PT SAMPLE. THE LAB MADE A BUFFY COAT SMEAR AND PERFORMED MANUAL DIFFERENTIAL ON WBC AND A RESULT OF 0.5 WAS REPORTED. THE INITIAL RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE PHYSICIAN QUESTIONED THE RESULTS AND HAD THE PT REDRAWN TWO HRS LATER. THE REDRAWN RESULTS WERE HIGHER. THE PT WAS DRAWN TWO DAYS LATER WITH SIMILAR WBC RESULTS AS THE REDRAWN SAMPLE. THERE ARE NO REPORTS OF ANY ADVERSE PT CONSEQUENCE OR ANY MEDICAL INTERVENTION TO PREVENT OR PRECLUDE ANY ADVERSE PT EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR