INSTRUMENT MANAGER SOFTWARE

Description of Event or Problem

ON 12/22/2025, DATA INNOVATIONS WAS MADE AWARE BY ABBOTT LABORATORIES, A DISTRIBUTOR OF INSTRUMENT MANAGER, THAT A USER FACILITY REPORTED AN HIV INTERPRETATION AS 'REACTIVE.' THE USER FACILITY EXPECTED THE INTERPRETATION TO BE 'NONREACTIVE.'

Additional Manufacturer Narrative

UPON INVESTIGATION, ABBOTT LABORATORIES DETERMINED THAT RULES (USER PROGRAMMED LOGIC) WERE NOT FUNCTIONING AS INTENDED DUE TO THE PROGRAMMING OF THOSE RULES. THE USER FACILITY'S RULE IS PROGRAMMED, SO THAT WHEN AN HIV RESULT (RESULT 1) IS GREATER THAN OR EQUAL TO 1.0, A RULE IN INSTRUMENT MANAGER WILL HOLD THE RESULT AND ORDER TWO ADDITIONAL REPEAT HIV TESTS (RESULT 2 AND RESULT 3). THE RULE IS WRITTEN, SO IF EITHER RESULT 2 OR RESULT 3 ARE GREATER THAN OR EQUAL TO 1.0, THEN THE FINAL RESULT INTERPRETATION IS LABELED AS 'REACTIVE' BECAUSE 2 OF THE 3 TOTAL RESULTS ARE GREATER THAN OR EQUAL TO 1.0. FOR EXAMPLE, HIV RESULT 1 WAS 1.60, WAS HELD BY INSTRUMENT MANAGER AND TWO ADDITIONAL REPEAT HIV TESTS WERE ORDERED. HIV RESULT 2 WAS 0.11 AND HIV RESULT 3 WAS 1.09. THE RULE WAS APPLIED BECAUSE RESULT 3 (1.09) WAS GREATER THAN 1.0, AND THE FINALIZED INTERPRETATION WAS LABELED AS 'REACTIVE.' THE USER FACILITY EXPECTED THE RULE TO AVERAGE RESULT 2 AND RESULT 3 AND NOT EVALUATE THEM SEPARATELY. THE AVERAGE OF RESULT 2 (0.11) AND RESULT 3 (1.09) WOULD HAVE BEEN 0.60 AND THE USER FACILITY EXPECTED THAT THE FINALIZED INTERPRETATION WOULD HAVE BEEN LABELED 'NONREACTIVE' BECAUSE THE AVERAGED RESULT WAS LESS THAN 1.0, HOWEVER THE RULE IS WRITTEN TO LOOK AT RESULT 2 AND RESULT 3 SEPARATELY AND NOT THE LAST TWO RESULTS AVERAGED. THE DISTRIBUTOR IS WORKING WITH THE USER FACILITY TO REVISE THE RULE TO FUNCTION AS INTENDED. THE MANUFACTURER AND DISTRIBUTOR WERE ABLE TO CONFIRM THAT INSTRUMENT MANAGER IS WORKING AS INTENDED. WHILE THIS IS NOT A MALFUNCTION OF THE INSTRUMENT MANAGER MEDICAL DEVICE IT IS BEING REPORTED DUE TO THE FACILITY'S INABILITY TO PROVIDE A STATEMENT OF PATIENT IMPACT DUE TO THE INCORRECT USER PROGRAMMED LOGIC.