ALINITY I INSULIN REAGENT KIT

Description of Event or Problem

THE CUSTOMER OBSERVED ELEVATED ALINITY I INSULIN RESULTS. (B)(6) 2025: C-PEPTIDE: 22.2 NG/ML, INSULIN: 28.08 UU/ML, GLUCOSE: 117 (NO UNIT OF MEASUREMENT PROVIDED). (B)(6) 2025: C-PEPTIDE: 43.96 NG/ML, INSULIN: 225.7 UU/ML, GLUCOSE: 131. ROCHE ECLIA METHOD: C-PEPTIDE: 38.8 NG/ML, INSULIN: 247.1 UU/ML. (B)(6) 2026: SID (B)(6): C-PEPTIDE: 4.12 NG/ML, INSULIN: 6.4 UU/ML, GLUCOSE: 106. THE PATIENT IS 77 YEAR OLD, MALE, WITH NO ABNORMALITIES IN GLUCOSE METABOLISM, AND CURRENTLY UNDERGOING TREATMENT FOR STOMACH CANCER, WITH TOTAL GASTRECTOMY PERFORMED IN DECEMBER. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

THE DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORTED THE COMPLAINT ISSUE. A REVIEW OF TRACKING AND TRENDING FOR THE ALINITY I INSULIN ASSAY DID NOT IDENTIFY ANY TRENDS RELATED TO THE COMPLAINT ISSUE. ADDITIONALLY, AN INCREASE IN COMPLAINT ACTIVITY WAS NOT IDENTIFIED FOR REAGENT LOT 83511LP97. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT IDENTIFY ANY NON-CONFORMANCES, POTENTIAL NON-CONFORMANCES, OR DEVIATIONS WITH LOT 83511LP97 AND THE COMPLAINT ISSUE. HISTORICAL PERFORMANCE OF THE ALINITY I INSULIN REAGENT LOT 83511LP97 WAS REVIEWED USING FIELD DATA FROM CUSTOMERS WORLDWIDE. THE PATIENT¿S DATA WAS ANALYZED AND COMPARED TO AN ESTABLISHED CONTROL LIMIT. THE PATIENT MEDIAN RESULT FOR LOT 83511LP97 IS WITHIN THE ESTABLISHED CONTROL LIMITS; THEREFORE, NO UNUSUAL REAGENT LOT PERFORMANCE WAS IDENTIFIED. A REVIEW OF LABELING WAS PERFORMED AND FOUND TO SUFFICIENTLY ADDRESS THE CUSTOMER'S ISSUE. BASED ON THIS INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED WITH THE ALINITY I INSULIN REAGENT, LOT NUMBER 83511LP97.

Description of Event or Problem

THE CUSTOMER OBSERVED ELEVATED ALINITY I INSULIN RESULTS. (B)(6) 2025: C-PEPTIDE: 22.2 NG/ML, INSULIN: 28.08 UU/ML, GLUCOSE: 117 (NO UNIT OF MEASUREMENT PROVIDED). (B)(6) 2025: C-PEPTIDE: 43.96 NG/ML, INSULIN: 225.7 UU/ML, GLUCOSE: 131. ROCHE ECLIA METHOD: C-PEPTIDE: 38.8 NG/ML, INSULIN: 247.1 UU/ML. (B)(6) 2026: SID (B)(6): C-PEPTIDE: 4.12 NG/ML, INSULIN: 6.4 UU/ML, GLUCOSE: 106. THE PATIENT IS 77-YEAR-OLD, MALE, WITH NO ABNORMALITIES IN GLUCOSE METABOLISM, AND CURRENTLY UNDERGOING TREATMENT FOR STOMACH CANCER, WITH TOTAL GASTRECTOMY PERFORMED IN (B)(6). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

COMPLETE ENTRY FOR SECTION A1 - PATIENT IDENTIFIER: (B)(6). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.