MAUDE Adverse Event Report: TOMTEC IMAGING SYSTEMS GMBH TOMTEC-ARENA TTA2; IMAGE REVIEW AND QUANTIFICATION SOFTWARE

Model Number	TTA2
Medical Device Problem Code	Patient Data Problem (3197)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A thorough evaluation of this event will be included in a follow-up report upon investigation completion.
Event or Problem Description
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.
Additional Manufacturer Narrative
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
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
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.

• Brand Name: TOMTEC-ARENA TTA2
• Common Device Name: IMAGE REVIEW AND QUANTIFICATION SOFTWARE
• Manufacturer (Section D): TOMTEC IMAGING SYSTEMS GMBH; edisonstrasse 6; unterschleissheim, 85716 ; GM 85716
• MDR Report Key: 9086360
• Report Number: 8043836-2019-00001
• Device Sequence Number: 2298528
• Product Code: LLZ
• UDI-Device Identifier: 04260361440143
• UDI-Public: (01)04260361440143(11)161028(10)20.14
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K150122
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: TTA2
• Device Lot Number: 20.14
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/29/2019
• Supplement Date Received by Manufacturer: 05/29/2019; 05/29/2019; 05/29/2019
• Initial Report FDA Received Date: 09/19/2019
• Supplement Report FDA Received Date: 11/12/2019; 12/20/2019; 05/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 8043836-10/02/19-001-C
• Patient Sequence Number: 1