MAUDE Adverse Event Report: VENTANA MEDICAL SYSTEMS INC UPATH ENTERPRISE SOFTWARE, IVD; MICROSCOPE, AUTOMATED, IMAGE ANALYSIS, IMMUNOHISTOCHEMISTRY,

Catalog Number 08991880001

Device Problem Application Program Problem (2880)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/09/2023

Event Type  malfunction  

Event Description

A customer from the united states was doing a comparison of the virtuoso versus the upath viewers and observed discrepant results with the upath software ivd - 1.X.The algorithm er (sp1) is used to detect estrogen receptor (er), a marker of breast cancer.The result provided by the algorithm analysis is the percent of er positivity.The customer is using er (sp1) fov algorithm to analyze breast slides.When comparing the results of the algorithm analysis using virtuoso 5.6.2 and upath 1.X, they observed that upath provided a lower percent positivity than virtuoso.The same version of the algorithm is used in virtuoso and upath.The upath result was not reported out to the patient.

Manufacturer Narrative

The issue was able to be reproduced.It has been confirmed that due to a source code error in the upath viewer, the input parameters were not sent to the algorithm.When the algorithm does not receive the necessary input parameters, it uses the default value for those parameters.Therefore, the results between virtuoso and upath for the same region of interest (roi) were discrepant.Note, virtuoso was correctly sending the input parameters, and therefore the algorithm analysis was performed as expected.Common device name truncated due to character limit: microscope, automated, image analysis, immunohistochemistry,operator intervention,nuclear intensity & percent positivity.

• Brand Name: UPATH ENTERPRISE SOFTWARE, IVD
• Type of Device: MICROSCOPE, AUTOMATED, IMAGE ANALYSIS, IMMUNOHISTOCHEMISTRY,
• Manufacturer (Section D): VENTANA MEDICAL SYSTEMS INC; 1910 e innovation park dr; tucson AZ 85755
• Manufacturer (Section G): VENTANA MEDICAL SYSTEMS INC; 1910 e innovation park dr; na; tucson AZ 85755
• Manufacturer Contact: timothy blair ; 1080 us hwy 202 s; building 500, room: 3530; branchburg, NJ 08876 ; 9253534412
• MDR Report Key: 16627639
• MDR Text Key: 312131224
• Report Number: 2028492-2023-00024
• Device Sequence Number: 1
• Product Code: NQN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/28/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 08991880001
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/27/2023
• Initial Date FDA Received: 03/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1