BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH750 HEMATOLOGY ANALYZER

    MDR report key: 2172106 · Received June 15, 2011

    Report

    Report Number
    1061932-2011-00617
    Event Type
    Malfunction
    Date Received
    June 15, 2011
    Date of Event
    July 8, 2009
    Report Date
    July 9, 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 HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED FOR THE PERIOD BETWEEN (B)(4) 2008 AND (B)(4) 2010, OF COMPLAINTS FOR ADDITIONAL REPORTABLE EVENTS. ON (B)(4) 2009, A FIELD SERVICE ENGINEER VISITED THE SITE TO EVALUATE THE LH750 ANALYZER. HE PERFORMED A CBC (COMPLETE BLOOD COUNT) LATEX CALIBRATION AND VERIFIED LYSE DILUENT TIMING AND INSTRUMENT PERFORMANCE. RAW DATA FILES WERE NOT PROVIDED FOR ANALYSIS. THE ROOT CAUSE FOR THIS EVENT IS UNK.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE LH750 HEMATOLOGY ANALYZER GENERATED ERRONEOUS WBC (WHITE BLOOD CELL) COUNTS ON A SAMPLE FROM ONE PT ON INITIAL TESTING AND ON REPEAT TESTING. THE ANALYZER DETECTED A SIGNAL FOR CELLULAR INTERFERENCE FOR THIS SAMPLE AND, IN ACCORDANCE WITH THE SOFTWARE ALGORITHM, CORRECTED THE WBC COUNT BY SUBTRACTING OUT THE "INTERFERENCE" AND GENERATING A CORRECTED WBC COUNT. IN FACT, THE WBC RESULTS SHOULD NOT HAVE BEEN CORRECTED, THAT IS, THE ORIGINAL, UNCORRECTED WBC RESULTS SHOULD HAVE BEEN REPORTED BY THE ANALYZER. THE LH750 ANALYZER GENERATED MESSAGES OF CELLULAR INTERFERENCE WITH THE SAMPLE RESULTS, ALONG WITH THE COMMENT "WBC ESTIMATE. REPEAT AND PERFORM SMEAR REVIEW." THE ERRONEOUS WBC COUNT RESULT WAS REPORTED OUT OF THE LAB. THE CUSTOMER SUBSEQUENTLY PERFORMED A MANUAL SMEAR REVIEW AND ALSO PROCESSED THE SAMPLE ON A SECOND LH750 ANALYZER (SN (B)(4)) PRESENT IN THE LAB. THERE WAS NO CELLULAR INTERFERENCE FLAG WITH TEST RESULTS AND THE WBC COUNT AGREED WITH THE MANUAL SMEAR EXAMINATION. THE CUSTOMER BELIEVED THESE RESULTS TO BE CORRECT. A CORRECTED REPORT WAS ISSUED. THERE WERE NO REPORTED CHANGES TO PT TREATMENT AS A RESULT OF THIS INCIDENT.

    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 86 YR