ALINITY I INSULIN REAGENT KIT

Additional Manufacturer Narrative

THE COMPLAINT EVALUATION FOR FALSELY ELEVATED ALINITY I INSULIN RESULTS INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, DEVICE HISTORY RECORD REVIEW, AND FIELD DATA REVIEW. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. REVIEW OF TRACKING AND TRENDING FOR THE ALINITY I INSULIN ASSAY DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY RELATED TO THE COMPLAINT ISSUE. ADDITIONALLY, AN INCREASE IN COMPLAINT ACTIVITY WAS NOT IDENTIFIED FOR REAGENT LOT 80511LP88 AND SUBLOT LP88. THE DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NONCONFORMANCES, POTENTIAL NONCONFORMANCE, OR DEVIATIONS ASSOCIATED WITH THE LOT AND COMPLAINT ISSUE. THE OVERALL PERFORMANCE OF ALINITY I INSULIN REAGENTS IN THE FIELD WAS REVIEWED USING DATA FROM CUSTOMERS WORLDWIDE. THE PATIENT¿S DATA WAS ANALYZED AND COMPARED TO AN ESTABLISHED CONTROL LIMIT. THIS EVALUATION INDICATED THAT THE PATIENT MEDIAN RESULT FOR LOT 80511LP88 IS WITHIN THE ESTABLISHED CONTROL LIMITS. THEREFORE, NO UNUSUAL REAGENT LOT PERFORMANCE WAS IDENTIFIED. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I INSULIN FOR LOT NUMBER 80511LP88 WAS IDENTIFIED. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

Description of Event or Problem

THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY I INSULIN RESULTS FOR A 77-YEAR-OLD MALE WITH A HISTORY OF GASTRIC CANCER, HYPOGLYCEMIA SECONDARY TO DUMPING SYNDROME (OCTOBER). THE PATIENT WAS UNDER THE METABOLIC MEDICINE DEPARTMENTS CARE FOR POST-OPERATIVE HYPOGLYCEMIC EPISODE (OCTOBER) BUT IS NOT CURRENTLY EXPERIENCING HYPOGLYCEMIA. THE PATIENT DID NOT HAVE ANY FINDINGS IN THE PANCREAS, NOR DID THE PATIENT HAVE INSULIN ADMINISTERED. THE FOLLOWING DATA WAS REPORTED: HISTORICAL RESULTS PROVIDED FROM (B)(6): INSULIN RESULT = 22 UU/ML ON (B)(6) 2025, SID (B)(6): INSULIN RESULT AT 15:16 = 225.7UU/ML (RAW RESULT OF 225.734 UU/ML) INSULIN 1:2 DILUTION RESULT AT 15:53 = 232.6 UU/ML (RESULT VALUE PROVIDED WITHOUT MULTIPLYING THE DILUTION FACTOR OF 2 = 116.3 UU/ML (RAW RESULT OF 116.294 UU/ML)) UNDILUTED INSULIN RESULT AT 16:09 = 228.2 UU/ML (RAW RESULT OF 228.233 UU/ML) OTHER LABORATORY TESTS PROVIDED: CEA RESULT AT 15:15 = 1.45 NG/ML CA 19-9 RESULT AT 15:16 = 14.41 U/ML GLUCOSE LEVELS: PREVIOUS RESULT = 117; CURRENT RESULT (TODAY) = 131 THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

Additional Manufacturer Narrative

SECTION A1, PATIENT IDENTIFIER COMPLETED INFORMATION: (B)(6). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

Description of Event or Problem

THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY I INSULIN RESULTS FOR A 77-YEAR-OLD MALE WITH A HISTORY OF GASTRIC CANCER, HYPOGLYCEMIA SECONDARY TO DUMPING SYNDROME (OCTOBER). THE PATIENT WAS UNDER THE METABOLIC MEDICINE DEPARTMENTS CARE FOR POST-OPERATIVE HYPOGLYCEMIC EPISODE (OCTOBER) BUT IS NOT CURRENTLY EXPERIENCING HYPOGLYCEMIA. THE PATIENT DID NOT HAVE ANY FINDINGS IN THE PANCREAS, NOR DID THE PATIENT HAVE INSULIN ADMINISTERED. THE FOLLOWING DATA WAS REPORTED: HISTORICAL RESULTS PROVIDED FROM (B)(6). INSULIN RESULT = 22 UU/ML. ON (B)(6) 2025, SID (B)(6): INSULIN RESULT AT 15:16 = 225.7UU/ML (RAW RESULT OF 225.734 UU/ML). INSULIN 1:2 DILUTION RESULT AT 15:53 = 232.6 UU/ML (RESULT VALUE PROVIDED WITHOUT MULTIPLYING. THE DILUTION FACTOR OF 2 = 116.3 UU/ML (RAW RESULT OF 116.294 UU/ML). UNDILUTED INSULIN RESULT AT 16:09 = 228.2 UU/ML (RAW RESULT OF 228.233 UU/ML). OTHER LABORATORY TESTS PROVIDED: CEA RESULT AT 15:15 = 1.45 NG/ML. CA 19-9 RESULT AT 15:16 = 14.41 U/ML. GLUCOSE LEVELS: PREVIOUS RESULT = 117; CURRENT RESULT (TODAY) = 131 THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.