OMNYX IDP SOFTWARE MEDIA BUNDLE VERSION 1.1

Description of Event or Problem

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.

Additional Manufacturer Narrative

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.