BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UPATH ENTERPRISE SOFTWARE, IVD

    MDR report key: 16627639 · Received March 28, 2023

    Report

    Report Number
    2028492-2023-00024
    Event Type
    Malfunction
    Date Received
    March 28, 2023
    Date of Event
    January 9, 2023
    Report Date
    March 28, 2023
    Manufacturer
    VENTANA MEDICAL SYSTEMS INC
    Product Code
    NQN
    PMA / PMN Number
    K140465
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332 UPATH ENTERPRISE SOFTWARE, IVD MICROSCOPE, AUTOMATED, IMAGE ANALYSIS, IMMUNOHISTOCHEMISTRY, NQN VENTANA MEDICAL SYSTEMS INC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown