BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITREA CT BRAIN PERFUSION

    MDR report key: 5101924 · Received September 24, 2015

    Report

    Report Number
    2134213-2015-00001
    Event Type
    Malfunction
    Date Received
    September 24, 2015
    Date of Event
    August 25, 2015
    Report Date
    December 17, 2015
    Manufacturer
    VITAL IMAGES, INC.
    Product Code
    LLZ
    PMA / PMN Number
    K121213
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER HAS PROVIDED US TWO DATASETS TO INVESTIGATE. THE RESULTS OF THE INVESTIGATION IDENTIFIED TWO SEPARATE ISSUES. ISSUE #1: UNEXPECTED MTT/CBF MAPS. THIS CUSTOMER STATED THE MTT/CBF MAPS APPEAR TO BE INVERTED. THE INVESTIGATION SHOWS THE DATASET HAS A TRUNCATED SCAN, THE TIME-DENSITY GRAPH SHOWS THAT THERE IS NOT ENOUGH WASHOUT FOR OUR SOFTWARE TO PRODUCE ACCURATE RESULTS. FROM OUR NEURO EDUCATION AND REFERENCE GUIDE (VPMC-13505 A, PAGE 122), WE STATE "CAUTION: FACTORS THAT CAN AFFECT THE ACCURACY OF THE RESULTS ARE: ·NOT FULLY CAPTURING THE CONTRAST BOLUS (INCLUDING AT LEAST 2 SECONDS OF PRE-ENHANCEMENT IMAGES AND POST-ENHANCEMENT)." ALSO, FROM OUR NEURO EDUCATION AND REFERENCE GUIDE (VPMC-13505 A, PAGE 128), WE INSTRUCT THE USER TO REVIEW THE TIME-DENSITY GRAPH. ADDITIONALLY, FROM OUR NEURO EDUCATION AND REFERENCE GUIDE (VPMC-13505 A, PAGE 152), WE PROVIDE EXAMPLES OF OPTIMAL AND SUB-OPTIMAL TIME-DENSITY GRAPHS. IN CONCLUSION: THE SOFTWARE HAS BEHAVED AS IT IS DESIGNED. DUE TO INCOMPLETE DATA, THE PERFUSION RESULTS COULD NOT HAVE BEEN CALCULATED ACCURATELY, ALTHOUGH THE SOFTWARE DID PRODUCE ACCURATE RESULTS WITH RESPECT TO THE INCOMPLETE DATA. THE SOFTWARE IS DESIGNED TO ASSIST THE USER IN THIS SITUATION BY PROMINENTLY DISPLAYING THE TIME-DENSITY GRAPH AND BY PROVIDING ACCURATE INSTRUCTIONS FOR USE ON HOW TO INTERPRET THE TIME-DENSITY GRAPH. ISSUE #2: CT PERFUSION RESULTS DO NOT AGREE WITH MR RESULTS FOR THIS ISSUE, THE USER STATED THEY WERE NOT CONFIDENT IN THE RESULTS PROVIDED BY OUR SOFTWARE AND PROCEEDED TO PERFORM AN MR SCAN TO OBTAIN ADDITIONAL INFORMATION. WHEN THE USER REVIEWED THE MR SCAN DATA, A CLEAR INFARCT WAS SHOWN, WHICH WAS NOT SHOWN BY THE CT PERFUSION RESULTS. A DETAILED INVESTIGATION WAS DONE, THE SUMMARY RESULTS ARE: THE CT PERFUSION RESULTS FROM OUR SOFTWARE ARE IN AGREEMENT WITH ANOTHER VENDOR'S ALGORITHM, WHICH SUGGESTS OUR SOFTWARE GENERATED THE RESULTS ACCURATELY BASED ON THE DATA. ADDITIONALLY, A VISUAL REVIEW OF THE CTA DATA SHOWS THAT THE CT PERFUSION RESULTS ARE IN AGREEMENT WITH THE CTA DATA, WHICH SUGGESTS THE SOFTWARE GENERATED RESULTS ACCURATELY.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS ONGOING WITH USER FACILITY.

    Description of Event or Problem · 1

    ON 08/25/2015, VITAL CUSTOMER SUPPORT RECEIVED A CALL FROM (B)(6) REGARDING DISPLAY OF INCORRECTLY INVERTED BRAIN PERFUSION COLOR MAPS (CBF AND MTT) ON OUR VITREA CT BRAIN PERFUSION 4D SOFTWARE APPLICATION. THE REPORTER INDICATED THAT A DELAY IN PATIENT TREATMENT HAD OCCURRED BECAUSE OF THE ISSUE. AGAIN ON 08/26/2015, THE SAME REPORTER INFORMED OUR CUSTOMER SUPPORT TEAM REGARDING ANOTHER PATIENT ISSUE WITH THE SOFTWARE IN WHICH THE CT BRAIN PERFUSION RESULT FROM OUR SOFTWARE WAS NOT IN AGREEMENT WITH THE PERFORMED MR RESULTS. THE MRI SHOWED AN OBVIOUS STROKE (INFARCT), WHILE THE CT PERFUSION RESULTS ON OUR SOFTWARE DID NOT. THE PATIENT WAS TREATED BASED ON MRI RESULTS.

    Description of Event or Problem · 1

    ON (B)(6) 2015, VITAL CUSTOMER SUPPORT RECEIVED A CALL FROM (B)(6) REGARDING DISPLAY OF INCORRECTLY INVERTED BRAIN PERFUSION COLOR MAPS (CBF AND MTT) ON OUR VITREA CT BRAIN PERFUSION 4D SOFTWARE APPLICATION. THE REPORTER INDICATED THAT A DELAY IN PATIENT TREATMENT HAD OCCURRED BECAUSE OF THE ISSUE. AGAIN ON (B)(6) 2015, THE SAME REPORTER INFORMED OUR CUSTOMER SUPPORT TEAM REGARDING ANOTHER PATIENT ISSUE WITH THE SOFTWARE IN WHICH THE CT BRAIN PERFUSION RESULT FROM OUR SOFTWARE WAS NOT IN AGREEMENT WITH THE PERFORMED MR RESULTS. THE MRI SHOWED AN OBVIOUS STROKE (INFARCT), WHILE THE CT PERFUSION RESULTS ON OUR SOFTWARE DID NOT. THE PATIENT WAS TREATED BASED ON MRI RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632054 VITREA CT BRAIN PERFUSION PICTURE ARCHIVING AND COMMUNICATION LLZ VITAL IMAGES, INC. VERSION 6.5.5 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other