STA COMPACT MAX

Description of Event or Problem

THROUGH THE TROUBLESHOOTING TO DETERMINE THE ROOT CAUSE FOR A PROFICIENCY (API 2025 HEMATOLOGY/COAGULATION-1ST EVENT) FAILURE ON INR, CUSTOMER REALIZED THAT THE ISI VALUE FOR STA NEOPLASTINE CI + (LOT 270708) WAS INCORRECT. DURING THE NEW LOT REAGENT CHANGE, AN ERRONEOUS VALUE OF 1.00 FOR ISI WAS INADVERTENTLY ENTERED BY THE LABORATORY INSTEAD OF APPLYING THE BAR-CODED ISI VALUE FOR THIS LOT (WHICH WAS SUPPOSED TO BE 1.31). CUSTOMER CORRECTED THE VALUE ON (B)(6) 2025 11:50 AM (FROM 1.00 TO 1.31). THE INSTRUMENT FILE DATA ANALYSIS SHOWED THAT THE INCORRECT ISI VALUE HAD BEEN SET ON (B)(6) 2024 07:04 AM. THE CUSTOMER RECALCULATED THE INR VALUES THAT WERE REPORTED BETWEEN (B)(6) 2024, AND (B)(6) 2025, AND COMPLETED THE PATIENT IMPACT ASSESSMENT. ACCORDING TO THIS EVALUATION, THE CUSTOMER'S ANTICOAGULATION PHARMACY IDENTIFIED ONE CASE OF SERIOUS INJURY, POTENTIALLY RELATED TO THE ERRONEOUS ISI VALUE. BASED ON ADDITIONAL INFORMATION OBTAINED FROM THE CUSTOMER EMDR THAT STAGO RECEIVED FROM FDA ON 10JUNE2025 (REF# MW5170914 -FOI), "THE DAY PRIOR TO PATIENT'S ADMISSION ((B)(6) 2025), THE INR WAS 2.7 TO TARGET OF 2.5 / 3.5 (WHEREAS WITH CORRECT ISI, INR = 3.7, ABOVE THE TARGET). THE DAY OF PATIENT'S ADMISSION ((B)(6) 2025), THE INR RESULT WAS 3.1 (WHEREAS WITH CORRECT ISI, INR = 4.4). VITAMIN K WAS GIVEN. NEUROSURGERY WAS CONSULTED AND THE PATIENT WAS ADMITTED FOR CLOSE OBSERVATION AND SERIAL IMAGING. NO OTHER INTERVENTION WAS NEEDED."

Additional Manufacturer Narrative

CUSTOMER CONFIRMED THAT THE INCIDENT WAS CAUSED BY A USER ERROR. NOTE THAT WARNINGS RELATED TO THE ISI MODIFICATION ARE DESCRIBED IN THE REFERENCE MANUAL OF THE INSTRUMENT (STA COMPACT MAX) AND THAT THE ACCESS TO THIS FEATURE IS ACCESSIBLE TO ONLY CERTAIN USER PROFILES. §4.2.6.6 CORRECTING THE ISI COEFFICIENT "THE ISI VALUE FOR THE PROTHROMBIN TIME MUST BE THE VALUE INDICATED ON THE INSERT INCLUDED IN THE STA® LINE PRODUCT. THE OPERATOR MUST CHECK THE ISI VALUE DISPLAYED ON THE SCREEN BEFORE QUITTING THE MENU IF THERE HAS BEEN A LOT CHANGE, A SOFTWARE UPDATE OR ANY OTHER MAJOR CHANGE. THE VALUE MUST CORRESPOND TO THE VALUE INDICATED ON THE INSERT INCLUDED IN THE STA® LINE PRODUCT. AN INCORRECT ISI VALUE CAN LEAD TO INCORRECT INR (INTERNATIONAL NORMALIZED RATIO) RESULTS. " "IF THE USER DOES NOT HAVE THE RIGHTS REQUIRED TO PERFORM THE MODIFICATION, AN ERROR MESSAGE IS DISPLAYED PREVENTING HIM/HER FROM SAVING THE CHANGES." IN CONCLUSION, NO MALFUNCTION OF THE INSTRUMENT WAS IDENTIFIED. THE ROOT CAUSE IS A USER ERROR. STAGO HAS CONCLUDED ITS INVESTIGATION IN THIS MATTER AND CONSIDERS IT IS A CONFIRMED AND ISOLATED EVENT. STAGO PLANS NO FURTHER ACTION. STAGO REFERENCE: (B)(4). MDR SUBMITTED BY THE MANUFACTURER. SEE IMPORTER REPORT NUMBER 2245451-2025-00001. SEE USER FACILITY REPORTED EMDR REFERENCE NUMBER MW5170914 -FOI.