BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNYX IDP SOFTWARE MEDIA BUNDLE VERSION 1.1

    MDR report key: 3535999 · Received October 21, 2013

    Report

    Report Number
    3008491142-2013-00001
    Event Type
    Malfunction
    Date Received
    October 21, 2013
    Date of Event
    September 20, 2013
    Report Date
    October 18, 2013
    Manufacturer
    OMNYX LLC
    Product Code
    OEO
    Removal / Correction Number
    3008491142-10/15/13-001-
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: ISSUE SUMMARY - A CUSTOMER REPORTED THAT ONE OF THE ANNOTATION TOOLS CONTAINED WITHIN THE DPS 1.1 SOFTWARE APPEARED TO MISCALCULATE THE AREA OF A REGION OF INTEREST ON A SCANNED SLIDE. EVAL - INVESTIGATION AT OUT COMPANY CONFIRMED THAT THE ANNOTATION TOOLS USED WITHIN THE DPS VERSION 1.1 IMAGE VIEWER WILL DISPLAY INCORRECT MEASUREMENTS AND AREA CALCULATIONS FOR A REGION OF INTEREST ON A SCANNED SLIDE, UNDER CERTAIN USE CONDITIONS. SOURCE CODE REVIEW IDENTIFIED WHERE THIS ERROR WAS INTRODUCED INTO DPS 1.1. CUSTOMER WAS INSTRUCTED NOT TO USE ANY AREA CALCULATIONS DISPLAYED BY THE VIEWER ANNOTATION TOOLS INCLUDING ALL SHAPES AND THE LINEAR MEASUREMENT TOOL UNTIL A SOLUTION COULD BE IDENTIFIED. CORRECTIVE ACTION - CUSTOMER WERE NOTIFIED OF A FIELD CORRECTIVE ACTION ON OR ABOUT (B)(4) 2013 AND WERE INSTRUCTED TO 1) DISCONTINUE USE OF THE MEASUREMENT AND AREA CALCULATION FEATURES OF THE ANNOTATION TOOLS (LINE, RECTANGLE/SQUARE, ELLIPSE/CIRCLE, AND FREEFORM) IN THE DPS IMAGE VIEWER; 2) VERIFY MEASUREMENTS AND CALCULATIONS ON GLASS SLIDES, IF ANY OF THE TOOLS HAVE BEEN USED FOR MEASUREMENTS OR AREA CALCULATIONS ON CLINICAL CASES; AND 3) NOTIFY ANY OTHER USERS OF THE SOFTWARE AT THEIR SITE OF THIS ISSUE. A NEW VERSION (1.2) OF DPS SOFTWARE IS CURRENTLY UNDER DEVELOPMENT. ENGINEERING IS REVIEWING AND REVISING TEST CASES TO ENSURE APPROPRIATE TEST CASE COVERAGE PRIOR TO EXECUTING FORMAL VERIFICATION TESTING. CUSTOMERS WILL BE PROVIDED WITH AN UPDATED VERSION OF THE SOFTWARE WHEN IT BECOMES AVAILABLE. THIS CORRECTION WAS REPORTED TO THE FDA (B)(4) DISTRICT OFFICE ON (B)(4) 2013 AS MEDICAL DEVICE CORRECTION AND REMOVAL REPORT NUMBER 3008491142-10/15/13-001-C.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT ONE OF THE ANNOTATION TOOLS CONTAINED WITHIN THE DPS 1.1 SOFTWARE APPEARED TO MISCALCULATE THE AREA OF A REGION OF INTEREST ON A SCANNED SLIDE. INTERNAL INVESTIGATION CONFIRMED THAT THE ANNOTATION TOOLS USED WITHIN THE DPS VERSION 1.1 IMAGE VIEWER WILL DISPLAY INCORRECT MEASUREMENTS AND AREA CALCULATIONS FOR A REGION OF INTEREST ON A SCANNED SLIDE, UNDER CERTAIN USE CONDITIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539478 OMNYX IDP SOFTWARE MEDIA BUNDLE VERSION 1.1 DIGITAL PATHOLOGY SOFTWARE OEO OMNYX LLC DPS S/W VERSION 1.1

    Patients

    Seq Age Sex Outcome Treatment
    1 Other