BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOMTEC-ARENA TTA2

    MDR report key: 7788665 · Received August 16, 2018

    Report

    Report Number
    8043836-2018-00001
    Event Type
    Malfunction
    Date Received
    August 16, 2018
    Date of Event
    July 19, 2018
    Report Date
    May 5, 2018
    Manufacturer
    TOMTEC IMAGING SYSTEMS GMBH
    Product Code
    LLZ
    UDI-DI
    04260361440143
    PMA / PMN Number
    K150122
    Removal / Correction Number
    8043836-10/02/19-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THIS ACTION WAS REPORTED TO FDA PER 21 CFR PART 806 ON 10/2/2019. REFERENCE CORRECTIONS AND REMOVAL REPORT NUMBER 8043836-10/02/19-001-C.

    Additional Manufacturer Narrative · 0

    THIS ACTION WAS REPORTED TO FDA PER 21 CFR PART 806 ON 10/2/2019. REFERENCE CORRECTIONS AND REMOVAL REPORT NUMBER (B)(4).

    Additional Manufacturer Narrative · 0

    A THOROUGH TECHNICAL INVESTIGATION WAS PERFORMED WHICH INCLUDED EVALUATION OF WORKFLOW DETAILS, A SOFTWARE DESIGN ISSUE WAS DETERMINED TO BE TO CAUSE AND A SOLUTION HAS BEEN INCLUDED IN A NEWLY RELEASED SOFTWARE REVISION.

    Additional Manufacturer Narrative · 1

    ALTHOUGH THIS ISSUE OCCURS WHEN A STUDY IS NOT CLOSED PRIOR TO BEGINNING THE NEXT STUDY AND HAS SINCE BEEN RESOLVED IN A NEWER LOT, A THOROUGH EVALUATION OF THIS EVENT WILL BE INCLUDED IN A FOLLOW-UP REPORT UPON INVESTIGATION COMPLETION.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A PATIENT DATA ERROR WHILE USING THE TOMTEC-ARENA. THE SOFTWARE ALLOWED PATIENT DATA ACQUIRED FROM ONE DATA SET TO BE INCLUDED IN THE NEXT PATIENT STUDY. THERE WAS NO MISDIAGNOSIS OR INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632841 TOMTEC-ARENA TTA2 IMAGE REVIEW AND QUANTIFICATION SOFTWARE LLZ TOMTEC IMAGING SYSTEMS GMBH TTA2 20.10 04260361440143

    Patients

    Seq Age Sex Outcome Treatment
    1 Other