BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROCHE DIGITAL PATHOLOGY DX /NAVIFY® DIGITAL PATHOLOGY (CLOUD)

    MDR report key: 25032476 · Received April 29, 2026

    Report

    Report Number
    2028492-2026-01689
    Event Type
    Malfunction
    Date Received
    April 29, 2026
    Date of Event
    March 30, 2026
    Report Date
    April 29, 2026
    Manufacturer
    VENTANA MEDICAL SYSTEMS INC.
    Product Code
    PSY
    PMA / PMN Number
    K242783
    Removal / Correction Number
    2028492-04-20-2026-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE NAVIFY® DIGITAL PATHOLOGY IS A COMPONENT OF THE ROCHE DIGITAL PATHOLOGY DX. ROCHE DIAGNOSTICS STARTED THE INVESTIGATION AND IDENTIFIED THE ROOT CAUSE. THE ISSUE WAS INTRODUCED IN NAVIFY® DIGITAL PATHOLOGY (NDP) VERSION 2.5, AND SUSTAINED IN VERSIONS 2.5.0.1, 2.5.0.2, AND 2.5.1 WHEN NEW SORTING LOGIC WAS APPLIED TO SPECIMEN LABELS BUT WAS NOT APPLIED TO THE CORRESPONDING WHOLE SLIDE IMAGES IN THE VIEWER WINDOW. WHILE SPECIMEN, BLOCK, AND IMAGE LABELS FOLLOW STRICT ALPHABETICAL ORDERING, WHOLE SLIDE IMAGES ARE SORTED INCONSISTENTLY DUE TO DIFFERENCES IN HOW THE USER INTERFACE SORTS NUMERIC VERSUS TEXT-BASED NAMES. THE MAIN CONTRIBUTING FACTOR IS THE CUSTOMER¿S NAMING CONVENTION FOR SPECIMENS. THE SOFTWARE ITSELF DOES NOT CURRENTLY PROVIDE ANY ERROR FLAG/MESSAGE FOR THIS ISSUE. A NEW SOFTWARE PATCH NDP V2.5.2 WAS RELEASED ON 23-APR-2026 AS A MANDATORY UPDATE TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 0

    HERE WAS AN ALLEGATION OF THE SLIDE IMAGES IN NAVIFY® DIGITAL PATHOLOGY (NDP) NOT ALIGNING WITH THE WHOLE SLIDE IMAGES. SPECIFICALLY, THE NDP APPLICATION DISPLAYS AN INCORRECT SLIDE IMAGE IN THE CASE OVERVIEW ON THE VIEWER SCREEN. ALTHOUGH THE IMAGE IS FROM THE SAME PATIENT, IT ORIGINATES FROM A DIFFERENT SPECIMEN. THIS ISSUE OCCURRED IN CASES WITH MULTIPLE SPECIMENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33818 ROCHE DIGITAL PATHOLOGY DX /NAVIFY® DIGITAL PATHOLOGY (CLOUD) WHOLE SLIDE IMAGING SYSTEM PSY VENTANA MEDICAL SYSTEMS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown