BEUDAMED
    FDA Adverse Event Other Summary report: N

    11X EXCITE MRI

    MDR report key: 1414607 · Received July 1, 2009

    Report

    Report Number
    2183553-2009-00036
    Event Type
    Other
    Date Received
    July 1, 2009
    Date of Event
    May 1, 2009
    Report Date
    June 5, 2009
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    LNH
    PMA / PMN Number
    K041476
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    GE'S PURE FEATURE IS DESIGNED TO MINIMIZE COIL INTENSITY VARIATIONS TO PROVIDE MORE UNIFORM IMAGE. INVESTIGATION WAS CONDUCTED THROUGH DATA PROCESSING AND ANALYSIS ON 7 EXAMS OBTAINED FROM THE HOSPITAL. THE EXAMS WERE PROCESSED WITH AND WITHOUT PURE. COMPARISON WITH THE NON-PURE IMAGES INDICATED ALL PURE IMAGES WERE OBSERVED TO HAVE RETAINED MORPHOLOGY AND KINETICS. THUS, CLINICAL EVALUATION ON THE PURE EXAMS REVEALED THAT THE FEATURE WAS FUNCTIONING AS EXPECTED. AS PART OF GE'S INVESTIGATION, CADSTREAM INDEPENDENT ANALYSES WERE OBTAINED FROM ITS MANUFACTURER CONFIRMA. ANALYSIS INCLUDED COMPARISON OF COLOR OVERLAYS AND SKIN DETECTION ON EXAMS PROCESSED WITH AND WITHOUT PURE. WHILE IT WAS FOUND THAT PURE DOES NOT CHANGE THE KINETIC CURVE SHAPE, THE FEATURE DOES REDUCE SIGNAL INTENSITY AND DYNAMIC RANGE OF THE IMAGES. FOR THIS REASON, CADSTREAM WOULD REQUIRE SETTING ADJUSTMENTS TO PRESENT COLOR EQUIVALENTLY IN PURE AND NON-PURE STUDIES. AS PROPER SETTINGS WERE APPLIED, CONFIRMA'S CONCLUSION INDICATED THAT CADSTREAM WITH THE USE OF PURE WAS FUNCTIONING AS EXPECTED. PER CONFIRMA, CADSTREAM'S COLOR OVERLAYS ARE NOT INTENDED TO DETECT AREAS OF INTEREST, BUT ARE TO BE USED AFTER IDENTIFYING AN AREA TO SUMMARIZE THE KINETICS. CADSTREAM'S USER MANUAL ALSO INSTRUCTS USER THAT PATIENT MANAGEMENT DECISIONS SHOULD NOT BE MADE BASED SOLEY ON THE RESULTS OF CADSTREAM ANALYSIS.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED TO GE THAT VIBRANT BREAST IMAGES WERE PROVIDING FALSE NEGATIVE DIAGNOSES WHEN USED WITH GE'S PHASED ARRAY UNIFORMITY ENHANCEMENT (PURE) FEATURE AND CONFIRMA'S CADSTREAM AUTO ANALYSIS. ACCOUNTS FROM THE HOSPITAL INDICATED THAT IT HAD STARTED USING PURE FILTER ON SOME BREAST EXAMS BEGINNING (B)(6) 2009; AND ON (B)(6) 2009, ITS USE WAS EXPANDED TO ALL BREAST EXAMS. IN (B)(6) 2009, THE HOSPITAL REPORTEDLY NOTICED A DECREASE IN THEIR BIOPSY RECOMMENDATION AND BEGAN TO QUESTION THE EFFECTIVENESS OF CADSTREAM. THE HOSPITAL NOTIFIED CONFIRMA. THE HOSPITAL LATER INFORMED GE OF SEVERAL CASES OF MISDIAGNOSES; 7 OF THESE CASES WERE ALLEGEDLY CALLED BACK FOR POSSIBLE BIOPSIES. IN ALL THESE CASES, GE'S PURE SETTING WAS USED WITH THE CADSTREAM TOOL. THE HOSPITAL HAD SINCE STOPPED USING PURE FOR BREAST MR EXAMS. NO FURTHER INFORMATION HAS BEEN PROVIDED BY THE HOSPITAL WITH RESPECT TO DETAILS ON AFFECTED PATIENTS AND THE ALLEGED MISDIAGNOSES. ATTEMPTS ARE BEING MADE TO OBTAIN FURTHER DETAILS FROM THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 11X EXCITE MRI LNH GE MEDICAL SYSTEMS, LLC 2294302

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other CADSTREAM SYSTEM MFG BY CONFIRMA