INSTRUMENT MANAGER SOFTWARE

Additional Manufacturer Narrative

INVESTIGATION WITH THE DISTRIBUTOR CONFIRMED THAT THE INSTRUMENT MANAGER (IM) LICENSE FILE WAS INCORRECTLY RENAMED WHILE THE SYSTEM WAS ACTIVELY RUNNING, CONSTITUTING A USE ERROR INCONSISTENT WITH THE INSTRUCTIONS FOR USE (IFU). SPECIFICALLY, THE DISTRIBUTOR MANUALLY RENAMED THE UPDATED LICENSE FILE FROM THE REQUIRED FILENAME "LICENSE.CACHE" TO "LICENSE.CACHE.CACHE." THE IFU DIRECTS USERS TO ACTIVATE A NEW LICENSE EXCLUSIVELY THROUGH THE IM ACTIVATE LICENSE FEATURE BY COPYING THE NEW LICENSE FILE TO THE SYSTEM. UPON FAILURE OF INSTRUMENT MANAGER TO INITIALIZE, THE DISTRIBUTOR RECEIVED AN ERROR MESSAGE INDICATING NO ACTIVE LICENSE FILE WAS DETECTED. THE DISTRIBUTOR IDENTIFIED THE FILE NAME DISCREPANCY, CORRECTED THE FILE NAME, AND INSTRUMENT MANAGER RESUMED NORMAL OPERATION. THE USER FACILITY CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THIS EVENT. DATA INNOVATIONS CONTINUES TO INVESTIGATE THE ROOT CAUSE OF THIS INCIDENT.

Description of Event or Problem

ROCHE DIAGNOSTICS, A DISTRIBUTOR OF INSTRUMENT MANAGER, REPORTED ON (B)(6) 2026 THAT AFTER ACTIVATING A NEW INSTRUMENT MANAGER (IM) LICENSE, A SPECIMEN RESULT WAS RELEASED TO THE PATIENT CHART WHEN IT SHOULD HAVE BEEN HELD FOR REVIEW. THE USER FACILITY EXPECTED THE RESULT OF "ALARM" TO BE HELD BY INSTRUMENT MANAGER TO ALLOW THE LABORATORY TECHNOLOGIST TO REVIEW THE RESULT BEFORE RELEASING.