BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UPATH SOFTWARE - SUPPORT

    MDR report key: 10382230 · Received August 7, 2020

    Report

    Report Number
    2028492-2020-00007
    Event Type
    Malfunction
    Date Received
    August 7, 2020
    Date of Event
    July 9, 2020
    Report Date
    December 22, 2020
    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
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 1

    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).

    Description of Event or Problem · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    846925 UPATH SOFTWARE - SUPPORT MICROSCOPE, AUTOMATED, IMAGE ANALYSIS NQN VENTANA MEDICAL SYSTEMS INC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1