BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOMTEC-ARENA TTA2

    MDR report key: 9087767 · Received September 19, 2019

    Report

    Report Number
    8043836-2019-00002
    Event Type
    Malfunction
    Date Received
    September 19, 2019
    Date of Event
    June 14, 2016
    Report Date
    May 5, 2020
    Manufacturer
    TOMTEC IMAGING SYSTEMS GMBH
    Product Code
    LLZ
    Removal / Correction Number
    8043836-10/02/19-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    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 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 8043836-10/02/19-001-C

    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

    CUSTOMER REPORTED THAT SWITCHING STUDIES CAUSES THE MEASUREMENT LIST TO KEEP MEASUREMENTS FROM THE PREVIOUS STUDY, AND MIXES THEM WITH THOSE FROM THE NEW ONE. MEASUREMENT LIST CONTAINS MEASUREMENTS FROM ANOTHER STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    883924 TOMTEC-ARENA TTA2 IMAGE REVIEW AND QUATIFICATION SOFTWARE LLZ TOMTEC IMAGING SYSTEMS GMBH TTA2 11.01

    Patients

    Seq Age Sex Outcome Treatment
    1