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 05/29/2019

Event Type  malfunction  

Manufacturer Narrative

A thorough evaluation of this event will be included in a follow-up report upon investigation completion.

Event 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.

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

This action was reported to fda per 21 cfr part 806.Reference corrections and removal report number 8043836-10/02/19-001-c.

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: 9086360
• MDR Text Key: 203498196
• Report Number: 8043836-2019-00001
• Device Sequence Number: 1
• Product Code: LLZ
• UDI-Device Identifier: 04260361440143
• UDI-Public: (01)04260361440143(11)161028(10)20.14
• Combination Product (y/n): N
• PMA/PMN Number: K150122
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2019
• 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: 20.14
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 8043836-10/02/19-001-C
• Patient Sequence Number: 1