BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOMTEC-ARENA TTA2

    MDR report key: 9911027 · Received April 1, 2020

    Report

    Report Number
    8043836-2020-00001
    Event Type
    Malfunction
    Date Received
    April 1, 2020
    Date of Event
    March 2, 2020
    Report Date
    October 5, 2020
    Manufacturer
    TOMTEC IMAGING SYSTEMS GMBH
    Product Code
    LLZ
    UDI-DI
    04260361440143
    PMA / PMN Number
    K150122
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    FOR THIS REPORTED ISSUE, ONLY A SMALL SUBSET OF MEASUREMENTS IS AFFECTED WHICH ARE PASSED THROUGH TO A THIRD PARTY SYSTEM. THE IMAGES AND MEASURMENT INFORMATION THAT ADDS TO DIAGNOSIS ACCORDING TO THE GUIDELINES OF THE SOCIETIES ARE NOT AFFECTED SO THAT THE HARM DOES RESULT INTO AN INJURY. FOR THIS REASON, THE SERVERITY FOR THIS INCIDENT IS RATED LEVEL 1. AN INTERNAL COMPLAINT ANALYSIS ADDITIONALLY PROVIDES EVIDENCE THAT THERE HAVE NOT BEEN REPORTS ABOUT DEATH OR SERIOUS INJURIES SO FAR.

    Description of Event or Problem · 0

    THE WORKFLOW TRIGGERING THE EVENT INVOLVES MULTIPLE SYSTEMS: MEASUREMENTS ARE DONE ON THE ULTRASOUND MODALITY AND THEN STUDIES ARE SENT IN TO ENTERPRISE IMAGING (EI) FROM AGFA. FROM EI CLIENT THE STUDIES ARE OPENED IN TOMTEC-ARENA FROM TOMTEC AND THE MEASUREMENTS ARE THEN EXPORTED VIA XML FILE TO THE CUPID SYSTEM FROM EPIC FOR REPORTING PURPOSE. IN SOME CIRCUMSTANCES IT HAPPENS THAT THE MEASUREMENTS FROM THE PREVIOUS PATIENT\STUDY IS SENT ADDITIONALLY TO EPIC CUPID FOR THE CURRENT ONE HOWEVER WITH THE CURRENT PATIENTS\STUDY DETAILS. THE SOFTWARE IS USED IN CLINICAL ROUTINE, THERE WAS NO INJURY OR SERIOUS DETERIORATION OF HEALTH STATE REPORTED WITH THIS EVENT. FIRST INVESTIGATIONS SHOW THAT THE ADDITION OF PREVIOUS MEASUREMENT DATA TO THE CURRENT EXPORT IS RELATED TO NONIMAGECOMFINDINGS (=IMPORTED MEASUREMENTS THAT ARE NOT MAPPED AND DISPLAYED IN THE EI/TOMTEC-ARENA SYSTEM BUT PASSED TO THE CUPID SYSTEM). IT ONLY HAPPENS IN CASE OF STUDIES ARE LAUNCHED WITHOUT NONIMAGECOMFINDINGS AND THE PREVIOUS LAUNCHED STUDY CONTAINED NONIMAGECOMFINDINGS. ALSO THE CONFIGURATION FLAG PASS THROUGH MEASUREMENTS FOR TOMTEC-ARENA NEEDS TO BE SET TO TRUE AND THE INTEGRATION SCENARIO OF TOMTEC-ARENA INTO A 3RD PARTY SYSTEM (TOMTEC-ARENA/EI IN THIS CASE) APPLIES A SPECIFIC LIFE-CYCLE MODE.

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS UNDERWAY TO DETERMINE THE ROOT CAUSE OF THE ISSUE. RESULTS OF THE INVESTIGATION WILL BE INCLUDED IN A FOLLOW UP REPORT UPON ITS COMPLETION.

    Description of Event or Problem · 1

    THE WORKFLOW TRIGGERING THE EVENT INVOLVES MULTIPLE SYSTEMS: MEASUREMENTS ARE DONE ON THE ULTRASOUND MODALITY AND THEN STUDIES ARE SENT IN TO ENTERPRISE IMAGING (EI) FROM AGFA. FROM EI CLIENT THE STUDIES ARE OPENED IN TOMTEC-ARENA FROM TOMTEC AND THE MEASUREMENTS ARE THEN EXPORTED VIA XML FILE TO THE CUPID SYSTEM FROM EPIC FOR REPORTING PURPOSE. IN SOME CIRCUMSTANCES IT HAPPENS THAT THE MEASUREMENTS FROM THE PREVIOUS PATIENT\STUDY IS SENT ADDITIONALLY TO EPIC CUPID FOR THE CURRENT ONE HOWEVER WITH THE CURRENT PATIENTS\STUDY DETAILS. THE SOFTWARE IS USED IN CLINICAL ROUTINE, THERE WAS NO INJURY OR SERIOUS DETERIORATION OF HEALTH STATE REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372990 TOMTEC-ARENA TTA2 IMAGE REVIEW AND QUANTIFICATION SOFTWARE LLZ TOMTEC IMAGING SYSTEMS GMBH TTA2 21.07 04260361440143

    Patients

    Seq Age Sex Outcome Treatment
    1