BEUDAMED
    FDA Adverse Event Other Summary report: N

    CADSTREAM

    MDR report key: 1414828 · Received July 10, 2009

    Report

    Report Number
    3003982333-2009-00001
    Event Type
    Other
    Date Received
    July 10, 2009
    Date of Event
    May 1, 2009
    Report Date
    June 10, 2009
    Manufacturer
    CONFIRMA, INC.
    Product Code
    LLZ
    PMA / PMN Number
    K043216
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONFIRMA WORKED WITH THE SITE FROM (B)(4) TO VERIFY THEIR CADSTREAM WAS WORKING APPROPRIATELY (STUDIES WERE PROCESSED AT THE SITE AND AT CONFIRMA AND SENT TO THE SITE TO COMPARE THE RESULTS). ADDITIONALLY, THE SITE PROVIDED STUDIES ACQUIRED WITH AND WITHOUT PURE TO GE ON (B)(4). GE FORWARDED THESE STUDIES TO CONFIRMA FOR ADDITIONAL ANALYSIS. CADSTREAM WAS FOUND TO BE WORKING AS DESIGNED AND INTENDED. BECAUSE THE PURE FILTER REDUCES THE PIXEL INTENSITY AND DYNAMIC RANGE IN THE IMAGES, THE STUDY PREFERENCES IN CADSTREAM NEEDED ADJUSTMENT TO APPLY COLOR OVERLAYS EQUIVALENTLY TO THE PURE FILTERED STUDIES AS TO NON-PURE FILTERED STUDIES. HOWEVER, THE SITE DID NOT NOTIFY CONFIRMA FOR ASSISTANCE WITH THIS SETUP PRIOR TO PROCESSING PURE STUDIES IN CADSTREAM, PER THE CADSTREAM USER DOCUMENTATION. ADDITIONALLY, THE RADIOLOGIST HAD BEEN USING CADSTREAM OFF-LABEL AND AGAINST ACR GUIDELINES IN RELYING SOLELY ON THE COLOR OVERLAYS FOR FOLLOW-UP DECISION-MAKING. CADSTEAM'S USER MANUAL ALSO INSTRUCTS USER THAT PATIENT MANAGEMENT DECISIONS SHOULD NOT BE MADE BASED SOLELY ON THE RESULTS OF CADSTREAM ANALYSIS.

    Description of Event or Problem · 1

    THE HOSPITAL HAS BEEN USING CADSTREAM FOR BREAST MRI REPORTING SINCE (B)(6) 2005. IN (B)(6) 2009, THEY STARTED USING GE'S PURE FILTER ON SOME OF THEIR BREAST EXAMS AND IN (B)(6) 2009 USED THE FILTER ON ALL BREAST EXAMS. IN (B)(6) 2009, THE SITE REALIZED THEY HAD BEEN REFERRING LESS PATIENTS TO BIOPSY AND ON (B)(6) CONTACTED CONFIRMA STATING THAT CADSTREAM WAS NOT PROCESSING CASES LIKE IT USED TO. THE SITE REPORTED THAT ENHANCING AREAS WERE NOT RECEIVING COLOR IN THE OVERLAYS COMPARED TO STUDIES FROM THE PREVIOUS YEAR THAT HAD AREAS OF COLOR ENHANCEMENT. CONFIRMA BEGAN TROUBLESHOOTING WITH THE SITE AND ON (B)(6) WAS INFORMED BY THE SITE ABOUT THE IMPLEMENTATION OF THE PURE FILTER AND THAT STUDIES WITHOUT THE FILTER LOOKED AS EXPECTED. CONFIRMA ASSISTED THE SITE IN MODIFYING THEIR STUDY PREFERENCES TO ADJUST FOR THE REDUCED DYNAMIC RANGE EXHIBITED BY STUDIES PROCESSED WITH THE PURE FILTER. ON (B)(6), THE SITE CONTACTED CONFIRMA AGAIN REPORTING THAT THEY NEED TO RE-READ 45 CASES THAT HAD THE PURE FILTER APPLIED. THE SITE ELECTED TO STOP USING PURE FOR BREAST MRI ON (B)(6). IN MID-(B)(6), CONFIRMA WAS NOTIFIED THROUGH GE HEALTHCARE THAT APPROX 7 OF THE 45 RE-READ CASES RESULTED IN PATIENTS BEING SENT FOR BIOPSY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CADSTREAM LLZ CONFIRMA, INC. VERSION 4.1.1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other 11X EXCITE MRI WITH PURE FILTER FROM GE HEALTHCARE