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.

• 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: 7812174
• Report Number: 8043836-2018-00002
• Device Sequence Number: 1747269
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/14/2018

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?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/19/2018
• Initial Report FDA Received Date: 08/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1