MAUDE Adverse Event Report: VENTANA MEDICAL SYSTEMS INC UPATH SOFTWARE - SUPPORT; MICROSCOPE, AUTOMATED, IMAGE ANALYSIS

Catalog Number 08991880001

Device Problem Computer Software Problem (1112)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/09/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation into this issue is currently on-going.The outcome of this investigation will be communicated through a follow-up report.Common classification name was truncated due to character limitations: microscope, automated, image analysis, immunohistochemistry, operator intervention, nuclear intensity and percent positivity.The material number for the ivd upath sw (b)(4) is 09077332001.The associated udi is (b)(4).

Event Description

An (b)(6) customer alleged that the slide image and slide thumbnail names do not match in the upath (b)(4) software.This software issue occurs only when one specimen is associated with multiple blocks and the name of the blocks is not following the same alphabetical order as the name of the slides.No harm or injury occurred as a result of the software issue.

Manufacturer Narrative

Investigation revealed that the procedure of the viewer initialization and the procedure of the label initialization do not execute at same time within the same software scope, thus a programming mistake of not sorting in the viewer initialization causes the mismatch of the label.For this defect to manifest at all, the case must be manually created in the system such that the alphanumeric ordering of the blocks and slides are different.Additionally, the ¿slide name¿ field must be used by the user in a way that could potentially cause confusion such as using this field to label ihc assay names.From an interpretation perspective, the affected assays would need to have similar staining patterns such that the false result was believable (e.G.Affected assays both have nuclear localization).The probability of detection is high since the correct slide label name is present in multiple other locations on the upath interface screen.Given all of these considerations, the most likely outcome is that the defect would not have any health consequences.Although confusion between slides theoretically could have clinical/treatment impact (e.G.Companion diagnostics) leading to adverse health consequences, this outcome is not likely.A new software patch upath 1.1.1 that provides the fix for this issue was released on 25-nov-2020.

• Brand Name: UPATH SOFTWARE - SUPPORT
• Type of Device: MICROSCOPE, AUTOMATED, IMAGE ANALYSIS
• Manufacturer (Section D): VENTANA MEDICAL SYSTEMS INC; 1910 e innovation park dr; tucson AZ 85755
• MDR Report Key: 10382230
• MDR Text Key: 209424608
• Report Number: 2028492-2020-00007
• Device Sequence Number: 1
• Product Code: NQN
• Combination Product (y/n): N
• PMA/PMN Number: K140465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 12/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 08991880001
• Date Manufacturer Received: 11/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1