BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOMTEC-ARENA TTA2

    MDR report key: 9086360 · Received September 19, 2019

    Report

    Report Number
    8043836-2019-00001
    Event Type
    Malfunction
    Date Received
    September 19, 2019
    Date of Event
    May 29, 2019
    Report Date
    May 5, 2020
    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
    US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

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

    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 · 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 · 1

    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 MEASUREMENT DATA CAN APPEAR FROM A PREVIOUS STUDY ONTO A NEW STUDY IF AN ERROR MESSAGE APPEARS DURING LAUNCH WHILE USING THE TOMTEC-ARENA TTA 2. THIS EVENT OCCURRED DURING A RESEARCH STUDY. THERE WAS NO INJURY OR CLINICAL USE ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    879683 TOMTEC-ARENA TTA2 IMAGE REVIEW AND QUANTIFICATION SOFTWARE LLZ TOMTEC IMAGING SYSTEMS GMBH TTA2 20.14 04260361440143

    Patients

    Seq Age Sex Outcome Treatment
    1