BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 500 HEMATOLOGY ANALYZER

    MDR report key: 2172324 · Received June 24, 2011

    Report

    Report Number
    1061932-2011-00661
    Event Type
    Malfunction
    Date Received
    June 24, 2011
    Date of Event
    December 15, 2008
    Report Date
    December 17, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K042723
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS DRAWN IN A PEDIATRIC TUBE/FINGER STICK. PREVIOUSLY-RUN PATIENT SAMPLES WERE RERUN TO CONFIRM ACCURATE BACK TO THE LAST ACCEPTABLE CONTROL RUN. THE UNIT WAS PERFORMING WITHIN QUALITY CONTROL SPECIFICATIONS. CONTROLS WERE RUN BEFORE AND AFTER THE INCIDENT AND RECOVERED WITHIN RANGE. ON (B)(4) 2008, THE FIELD SERVICE ENGINEER (FSE) REPLACED THE TUBING FOR THE TWO ASPIRATION PUMPS. THE FSE PERFORMED REPRODUCIBILITY AND VERIFIED INSTRUMENT PERFORMANCE. BASED ON THE AVAILABLE INFORMATION, THE ROOT CAUSE FOR ERRONEOUS RESULTS CAN BE ATTRIBUTED TO AN INADEQUATELY MIXED SAMPLE. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN 01/01/2008 AND 10/23/2010 OF COMPLAINTS FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ERRONEOUS TEST RESULTS FOR HEMOGLOBIN AND HEMATOCRIT FOR A SPECIFIC PATIENT SAMPLE WHEN USING THE COULTER LH 500 HEMATOLOGY ANALYZER. THE TEST RESULTS WERE DETERMINED TO BE ERRONEOUS WHEN COMPARED TO RERUNS PERFORMED THE NEXT DAY, AND RESULTS OBTAINED WITH A REDRAWN SPECIMEN. THE ERRONEOUS TEST RESULTS WERE REPORTED OUT OF THE LABORATORY. NO REPORTS OF DEATH OR SERIOUS INJURY, AND NO AFFECT TO PATIENT TREATMENT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER LH 500 HEMATOLOGY ANALYZER GKZ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR