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

Model Number TTA2

Device Problem Patient Data Problem (3197)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/19/2018

Event Type  malfunction  

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 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.

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.

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).

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
• Type of Device: IMAGE REVIEW AND QUANTIFICATION SOFTWARE
• Manufacturer (Section D): TOMTEC IMAGING SYSTEMS GMBH; edisonstrasse 6; unterschleissheim, 85716 ; GM 85716
• MDR Report Key: 7788665
• MDR Text Key: 117292285
• Report Number: 8043836-2018-00001
• Device Sequence Number: 1
• Product Code: LLZ
• UDI-Device Identifier: 04260361440143
• UDI-Public: (01)04260361440143(11)160809(10)20.10
• Combination Product (y/n): N
• PMA/PMN Number: K150122
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TTA2
• Device Lot Number: 20.10
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 8043836-10/02/19-001-C
• Patient Sequence Number: 1
• Patient Outcome(s): Other