BEUDAMED
    FDA Adverse Event Death Summary report: N

    VRAD PACS WITH MAMMOGRAPHY

    MDR report key: 24776400 · Received April 3, 2026

    Report

    Report Number
    3007795813-2026-90001
    Event Type
    Death
    Date Received
    April 3, 2026
    Date of Event
    April 30, 2023
    Report Date
    April 1, 2026
    Manufacturer
    VIRTUAL RADIOLOGIC CORPORATION
    Product Code
    LLZ
    UDI-DI
    00862234000313
    PMA / PMN Number
    K162145
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE RELATIONSHIP OF THE DEVICE TO THE UNDERLYING EVENT HAS NOT BEEN ESTABLISHED. THE PATIENT LIKELY DIED AS A RESULT OF HER UNDERLYING CONDITION, BUT TTHE MDR IS BEING FILED IN AN ABUNDANCE OF CAUTION TO ENSURE FULL COMPLIANCE WITH 21 CFR PART 803. VRAD CORRECTED THE ISSUE BEFORE BECOMING AWARE OF PATIENT'S DEATH. VRAD SUBMITTED 806 FIELD CORRECTION REPORT 12 JUN 2023 AND WAS ASSIGNED EVENT NUMBER 92516. ON FEBRUARY 16, 2023, VRAD RELEASED A PERFORMANCE UPDATE TO VRAD PACS WITH MAMMOGRAPHY. THE UPDATE INCLUDED A CODE-CHANGE THAT WAS LATER FOUND TO PERMIT A COMPARISON STUDY TO DISPLAY, EVEN IF THE PRIMARY STUDY HAD NOT COMPLETED LOADING (MULTI-THREADING TIMING). DESPITE DESIGN VERIFICATION AND VALIDATION ACTIVITIES ASSOCIATED WITH THE CODE-CHANGE, THE MULTI-THREADING TIMING ISSUE WAS NOT IDENTIFIED DURING THE CHANGE CONTROL PROCESS. EVIDENCE OF THE TESTING THAT WAS PERFORMED AT THE TIME, WHICH INCLUDED REGRESSION TESTING TO ENSURE THE CHANGE DID NOT ENCUMBER ANY EXISTING FUNCTIONALITY, WAS PROVIDED DURING THE INSPECTION AND IS THUS NOT BEING PROVIDED WITH THIS RESPONSE DUE TO THE VOLUME OF DOCUMENTATION. SHORTLY AFTER RELEASE OF THE CODE IN FEBRUARY OF 2023, VRAD WAS NOTIFIED BY USERS OF AN ISSUE IN WHICH THE CURRENT STUDY DID NOT LOAD BEFORE PRIOR STUDIES WERE LOADED. VRAD ENGINEERS INVESTIGATED THE ISSUE AND QUICKLY BEGAN WORKING ON A FIX. AS PART OF THE REVIEW INTO THE ISSUE, VRAD DETERMINED THAT THE FREQUENCY OF OCCURRENCE WAS LOW (0.16%). THE MALFUNCTION OCCURRED INFREQUENTLY, AND WAS NOT EXPECTED TO RESULT IN PATIENT HARM DUE TO THE PRIOR STUDY IMAGES BEING CLEARLY IDENTIFIED AS SUCH. SEE "VISUAL CUES" BELOW VISUAL CUES: THE PRIOR DEVICE AND THE CURRENT VIEWER INCLUDE FEATURES TO ENHANCE THE VISUAL DISTINCTION BETWEEN CURRENT STUDY AND COMPARISON (PRIOR STUDY) IMAGES, THEREBY REDUCING THE RISK OF MISINTERPRETING A PRIOR STUDY AS IF IT IS THE CURRENT STUDY. THESE FEATURES CONTINUE TO EXIST IN TODAY'S VIEWER. THE INSTRUCTIONS FOR USE IN THE USER GUIDE PROVIDE TEXT AND VISUAL EXAMPLES OF THESE DISTINCTIONS. THE DISTINCTIONS INCLUDE: 1. COMPARISON LABEL: THE WORD "COMPARISON" APPEARS IN HIGH-CONTRAST FONT AT THE TOP OF ANY WINDOW DISPLAYING COMPARISON IMAGES; 2. TEXT OVERLAY COLOR: THE CONFIGURABLE COLOR SCHEME WILL ALWAYS DISPLAY A CURRENT STUDY AS A DIFFERENT COLOR THAN THE PRIOR STUDY, REGARDLESS OF WHICH MONITOR THE IMAGES ARE DISPLAYED ON; 3. USER ACTION REQUIRED: IMAGES ARE DISPLAYED AS THUMBNAILS OR ALONG AN EDGE OF THE DISPLAY UNTIL THE USER SELECTS THE IMAGE TO DISPLAY IN THE ACTIVE WINDOW; 4. WINDOW BORDER: THE BORDER HIGHLIGHT AROUND THE ACTIVE WINDOW (I.E., THE WINDOW IN WHICH A RADIOLOGIST IS SCROLLING, MEASURING, ETC.) AND THE CORRESPONDING THUMBNAIL FOR THE IMAGE SERIES ARE THE SAME COLOR AS THE TEXT OVERLAY IN THE WINDOW; 5. DATE VISIBILITY: THE DATE AND TIME THE STUDY WAS IMAGED IS ALWAYS VISIBLE WHEN A STUDY LAUNCHES; AND 6. HANGING PROTOCOL: THERE IS A CONSISTENT "HANGING" LOCATION IN WHICH PRIMARY AND COMPARISON IMAGES APPEAR. THE MALFUNCTION COULD ONLY IMPACT A PATIENT IF THE USER BYPASSED SEVERAL VISUAL CUES THAT THE STUDY BEING INTERPRETED IS NOT THE PRIMARY STUDY, BUT RATHER IS A PRIOR STUDY. AS DESCRIBED IN MORE DETAIL BELOW, VRAD RECEIVED ONLY ONE REPORT IN WHICH THE ISSUE OCCURRED IN TANDEM WITH A PATIENT EVENT (THE EVENT ON (B)(6)). IN EVERY OTHER CASE THE ISSUE OCCURRED, THE READING RADIOLOGIST RELOADED THE IMAGES AND THE PRIMARY STUDY POPULATED AS EXPECTED. AS THE ISSUE PRESENTED AS A NUISANCE TO RADIOLOGISTS, VRAD INTENDED TO RELEASE A PATCH WITH ITS NEXT MONTHLY RELEASE. HOWEVER, THE RELEASE OF THE PATCH WAS EXPEDITED BECAUSE OF A COMPLAINT RECEIVED IN WHICH THE ERROR OCCURRED IN AN EVENT THAT ALSO INVOLVED A PATIENT ADVERSE EVENT. VRAD PERFORMED SEVERAL ACTIONS TO ADDRESS THE INTERMITTENT MULTI-THREADING TIMING ISSUE. THE FOLLOWING PROVIDES A SUMMARY OF THE KEY ACTIONS UNDERTAKEN BY THE COMPANY IN 2023. RISK ANALYSIS: VRAD CONDUCTED A RISK ASSESSMENT AND VERIFIED THAT FACTORS THAT CONTRIBUTE TO POTENTIAL HAZARDS WERE ALREADY IDENTIFIED IN THE PRIOR DEVICE'S RISK ASSESSMENT, INCLUDING: 1) MANUFACTURING PROBLEMS: SOFTWARE ENGINEERING COULD INTRODUCE CODE THAT DOES NOT PERFORM AS INTENDED ("A BUG") AND THE BUG MIGHT NOT BE IDENTIFIED IN PRE-PRODUCTION TESTING; 2) INPUT FACTORS: A HOSPITAL COULD PROVIDE CORRUPT OR INCOMPLETE INFORMATION; INTERNET FAILURE; AND 3) USER FACTORS: A RADIOLOGIST COULD INTERPRET A STUDY WITHOUT VERIFYING AT LEAST TWO IDENTIFIERS, THUS FAILING TO PROOFREAD BEFORE SIGNING REPORT. RETROSPECTIVE REVIEW: ON MAY 3, 2023, VRAD REVIEWED THE LOGS OF INSTALLED SYSTEMS SINCE THE FEBRUARY 16TH SOFTWARE RELEASE TO DETERMINE IF THERE WERE ANY OTHER INSTANCES OF PRIOR STUDIES BEING MISTAKENLY RELIED UPON AS A RESULT OF THE PRIMARY STUDY NOT LAUNCHING. EVEN THOUGH THE REVIEW FOUND THAT THE LOADING ISSUE HAD OCCURRED, NONE HAD RESULTED IN A PATIENT IMPACT BECAUSE THE RADIOLOGISTS EXPERIENCING THE ISSUE SIMPLY LAUNCHED THE CURRENT STUDY MANUALLY. THE ANALYSIS INDICATED THE RISK OF A PRIOR STUDY BEING MISINTERPRETED AS A CURRENT STUDY WAS APPROPRIATELY MITIGATED BY VISUAL CUES TO THE READING RADIOLOGIST. REMOVAL OF ROOT CAUSE CODE: ON MAY 4, 2023, VRAD REMOVED THE CODE THAT PERMITTED COMPARISON STUDIES TO RENDER BEFORE A PRIMARY STUDY LOADS. (IT IS IMPORTANT TO THE USERS TO ALLOW THE COMPARISON STUDIES TO CACHE WHILE THE PRIMARY STUDY IS LOADING, AS OPPOSED TO WAITING UNTIL THE PRIMARY STUDY HAS FULLY LOADED, TO MINIMIZE DELAY IN DIAGNOSIS OF THE PATIENT.) THE UPDATED SOFTWARE WAS RELEASED FOLLOWING QUALITY-ASSURANCE AND REGRESSION TESTING, INCLUDING TEST CASES DESIGNED TO CONFIRM PROPER HANDLING OF PRIMARY-STUDY LOADING FAILURES. FIELD ACTION: WHEN VRAD LEARNED THAT THE PATIENT FROM THE APRIL 30 EVENT HAD EXPIRED, VRAD INITIATED A FIELD CORRECTION IN WHICH EIGHT LICENSEES WERE NOTIFIED OF THE ISSUE. THIS FIELD ACTION WAS REPORTED TO FDA ON JUNE 7, 2023. VERIFICATION OF EFFECTIVENESS: FOLLOWING REMOVAL OF THE ROOT CAUSE CODE, VRAD REVIEWED SYSTEM LOGS AFTER THE ERROR WAS INTRODUCED TO CONFIRM THAT COMPARISON STUDIES DID NOT RENDER WITHOUT A PRIMARY STUDY LOADING. THAT VERIFICATION OCCURRED IN 2023. NO RECURRENCE OF THE ISSUE WAS IDENTIFIED IN THE PRIOR DEVICE (WHICH, AS NOTED ABOVE, IS NO LONGER REGULATED) OR THE CURRENT VRAD VIEWER. AS A RESULT OF THE FDA INSPECTION, ADDITIONAL VERIFICATION ACTIVITIES WERE PERFORMED ON MARCH 5, 2026 AND AGAIN MARCH 18, 2026. BETWEEN 3/18/2025 AND 3/18/2026, THE ISSUE OCCURRED 0 TIMES OUT OF OVER 8 MILLION VIEWING SESSIONS. ROOT CAUSE DETERMINATION - SOFTWARE: VRAD DETERMINED THAT IT DID NOT IDENTIFY THE LEGACY CODE THAT CAUSED THE ERROR WHEN THE 2023 PERFORMANCE UPDATE WAS INTRODUCED BECAUSE IT LACKED AN AUTOMATED TEST FOR LOADING ORDER SCENARIOS. VRAD HAS SINCE INTRODUCED AUTOMATED TESTING FOR THAT SCENARIO. IT SHOULD BE NOTED THAT EVEN AUTOMATED TESTING CANNOT ELIMINATE A RACE CONDITION FROM OCCURRING; IT ONLY REDUCES ITS LIKELIHOOD, SINCE SOFTWARE CAN BEHAVE DIFFERENTLY DEPENDING ON THE EXACT ORDER OR SPEED OF EVENTS. INTERMITTENT BUGS SHOW UP UNPREDICTABLY AND THUS SCENARIOS MUST RUN HUNDREDS OF THOUSANDS OF TIMES WITH SLIGHT TIMING VARIATIONS. THE MOST EFFECTIVE WAY TO ACHIEVE THAT VARIATION TESTING FOR AN ERROR THAT IS LOW-RISK, GIVEN THE DISTRIBUTED NATURE OF THE ENVIRONMENT IN WHICH VIEWER OPERATES IS MONITORING REAL-WORLD DATA PRODUCED IN OUR PRACTICE. ACCORDINGLY, ONCE VRAD BECAME AWARE OF THE ISSUE, IT WAS POSSIBLE TO ISOLATE TEXT IN THE LOG FILES THAT INDICATED THE ERROR AND PERFORM A SEARCH TO FIND INSTANCES WHERE THE ERROR OCCURRED. IN 2023, VRAD DETERMINED THE ROOT CAUSE TO BE A LACK OF CONTROLS TO PREVENT THE PRIOR STUDY FROM SHOWING BEFORE THE PRIMARY STUDY. VRAD IMPLEMENTED CONTROLS TO KEEP PRIOR CASES FROM BEING SHOWN UNTIL AT LEAST ONE PRIMARY STUDY WAS DISPLAYED. AUTOMATED TESTING FOR THIS RELEASE INCLUDED A SCENARIO WHERE THE PRIMARY STUDY FAILED TO LOAD BECAUSE OF AN ERROR. THE INTENT OF THIS CHANGE WAS TO PREVENT A PRIOR STUDY FROM BEING SHOWN BEFORE A PRIMARY STUDY, REGARDLESS OF LOAD ORDER.

    Description of Event or Problem · 0

    ON (B)(6) 2023, A RADIOLOGIST USING VRAD PACS WITH MAMMOGRAPHY EXPERIENCED AN INTERMITTENT SOFTWARE ANOMALY. THE SOFTWARE ANOMALY RESULTED IN PATIENT'S CURRENT RADIOLOGICAL IMAGE TO NOT LAUNCH, INDICATED BY A PERSISTENT "LOADING" MESSAGE DISPLAYED TO THE RADIOLOGIST USER. THE RADIOLOGIST THEN LAUNCHED A PRIOR STUDY (INDICATED BY A "COMPARISON" LABEL ON THE IMAGE), BYPASSING SEVERAL VISUAL CUES AND CONVENTIONS. THE RADIOLOGIST RENDERED AN INTERPRETATION BASED ON HISTORIC IMAGES THAT DID NOT CAPTURE THE PATIENT'S CURRENT, CRITICAL CONDITION, AND THE INTERPRETATION WAS SUBMITTED TO THE LOCAL TREATING FACILITY. ON 20-MAY-2023, VRAD LEARNED THE PATIENT DIED EARLIER IN THE MONTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839647 VRAD PACS WITH MAMMOGRAPHY VRAD PACS LLZ VIRTUAL RADIOLOGIC CORPORATION 00862234000313

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Female Death UNKNOWN - ANTICOAGULANTS