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	07/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
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.
Additional Manufacturer Narrative
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
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
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: 7788665
• Report Number: 8043836-2018-00001
• Device Sequence Number: 1188371
• Product Code: LLZ
• UDI-Device Identifier: 04260361440143
• UDI-Public: (01)04260361440143(11)160809(10)20.10
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K150122
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/05/2018

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: 20.10
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/19/2018
• Supplement Date Received by Manufacturer: 07/19/2018; 07/19/2018; 07/19/2018
• Initial Report FDA Received Date: 08/16/2018
• Supplement Report FDA Received Date: 11/21/2019; 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
• Outcome Attributed to Adverse Event: Other