ALINITY I FREE T4 REAGENT KIT

Additional Manufacturer Narrative

SECTION A PATIENT INFORMATION AND SECTION B5 HAVE BEEN UPDATED WITH ADDITIONAL DATA. CONCOMITANT PRODUCTS UPDATED WITH ADDITIONAL INFORMATION. SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION.

Description of Event or Problem

THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY I FREE T4 AND PROVIDED THE FOLLOWING DATA FOR SAMPLE ID (B)(6): ON (B)(6) THE RESULT WAS 1.33 NG/DL, ON (B)(6), THE RESULT WAS 1.75 NG/DL, ON (B)(6) THE RESULTS WERE 1.12 NG/DL & 1.10 NG/DL, CUSTOMER REFERENCE RANGE: 0.81 TO 1.32 NG/DL. PATIENT INFORMATION: 16 YEAR OLD FEMALE. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT. UPDATE: THE CUSTOMER REPORTED MORE PATIENTS WITH FALSELY ELEVATED ALINITY I FREE T4 AND PROVIDED THE FOLLOWING DATA: SAMPLE ID (B)(6) (MALE, 47 YEARS OLD): ON (B)(6) RESULTS WERE 1.09 NG/DL (FROM SN: (B)(6)) AND 2.28 NG/DL (FROM SN: (B)(6)), ON (B)(6) RESULTS WERE 1.05 NG/DL (FROM SN: (B)(6)) AND 1.03 NG/DL (FROM SN: (B)(6)). SAMPLE ID (B)(6) (FEMALE, 37 YEARS OLD) ON (B)(6) RESULTS WERE 1.14 NG/DL (FROM SN: (B)(6)) AND 1.42 NG/DL (FROM SN: (B)(6)), ON (B)(6) RESULTS WERE 1.08 NG/DL (FROM SN: (B)(6)) AND 1.09 NG/DL (FROM SN: (B)(6)). SAMPLE ID (B)(6) (GENDER AND AGE NOT PROVIDED): ON (B)(6) THE RESULT WAS 4.06 NG/DL (FROM SN: (B)(6)). ON (B)(6) THE RESULTS WERE 1.69 NG/DL (FROM SN: (B)(6)), 0.97 NG/DL (FROM SN: (B)(6)), 1.29 NG/DL (FROM SN: (B)(6)), 1.82 NG/DL (FROM SN: (B)(6)) & 0.96 NG/DL (FROM SN: (B)(6)). THE SAMPLE WAS TESTED FURTHER WITH SIEMENS ATELLICA AND GENERATED THE RESULTS OF 1.54 NG/DL & 1.31 NG/DL. SAMPLE ID (B)(6) (FEMALE, 61 YEARS OLD) ON (B)(6) THE RESULTS WERE 3.16 NG/DL, 1.98 NG/DL, 1.89 NG/DL, 1.40 NG/DL, & 1.32 NG/DL (FROM SN (B)(6)). THE SAMPLE WAS REPEATED ON SN: (B)(6) AND THE RESULTS WERE 1.60 NG/DL, 1.70 NG/DL, 1.76 NG/DL, 1.17 NG/DL, & 1.22 NG/DL. SAMPLE ID (B)(6) (MALE, 73 YEARS OLD): ON (B)(6) THE RESULT WAS 1.99 NG/DL (FROM SN (B)(6)). ON (B)(6) THE SAMPLE WAS REPEATED AND GENERATED THE FOLLOWING RESULTS OF 1.05 NG/DL (FROM SN: (B)(6)), 1.09 NG/DL (FROM SN: (B)(6)), 1.06 NG/DL AND 1.05 NG/DL (FROM SN: (B)(6)).

Additional Manufacturer Narrative

AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. A1 - PATIENT IDENTIFIER: (B)(6) (COMPLETE SAMPLE ID EXCEEDED CHARACTERS ALLOWED IN THIS FIELD).

Description of Event or Problem

THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY I FREE T4 AND PROVIDED THE FOLLOWING DATA FOR SAMPLE ID (B)(6): ON 3 JAN THE RESULT WAS 1.33 NG/DL ON 5 JAN, THE RESULT WAS 1.75 NG/DL ON 6 JAN THE RESULTS WERE 1.12 NG/DL & 1.10 NG/DL CUSTOMER REFERENCE RANGE: 0.81 TO 1.32 NG/DL PATIENT INFORMATION: 16-YEAR-OLD FEMALE. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

Description of Event or Problem

THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY I FREE T4 AND PROVIDED THE FOLLOWING DATA FOR SAMPLE ID (B)(6): ON (B)(6) THE RESULT WAS 1.33 NG/DL, ON (B)(6), THE RESULT WAS 1.75 NG/DL, ON (B)(6) THE RESULTS WERE 1.12 NG/DL & 1.10 NG/DL, CUSTOMER REFERENCE RANGE: 0.81 TO 1.32 NG/DL. PATIENT INFORMATION: 16 YEAR OLD FEMALE. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT. UPDATE: THE CUSTOMER REPORTED MORE PATIENTS WITH FALSELY ELEVATED ALINITY I FREE T4 AND PROVIDED THE FOLLOWING DATA: SAMPLE ID (B)(6) (MALE, 47 YEARS OLD): ON (B)(6) RESULTS WERE 1.09 NG/DL (FROM SN: (B)(6)) AND 2.28 NG/DL (FROM SN: (B)(6)) ON (B)(6) RESULTS WERE 1.05 NG/DL (FROM SN: (B)(6)) AND 1.03 NG/DL (FROM SN: (B)(6)). SAMPLE ID (B)(6) (FEMALE, 37 YEARS OLD): ON (B)(6) RESULTS WERE 1.14 NG/DL (FROM SN: (B)(6)) AND 1.42 NG/DL (FROM SN: (B)(6)) ON (B)(6) RESULTS WERE 1.08 NG/DL (FROM SN: (B)(6)) AND 1.09 NG/DL (FROM SN: (B)(6)). SAMPLE ID (B)(6) (GENDER AND AGE NOT PROVIDED): ON (B)(6) THE RESULT WAS 4.06 NG/DL (FROM SN: (B)(6)). ON (B)(6) THE RESULTS WERE 1.69 NG/DL (FROM SN: (B)(6)), 0.97 NG/DL (FROM SN: (B)(6)), 1.29 NG/DL (FROM SN: (B)(6)), 1.82 NG/DL (FROM SN: (B)(6)) & 0.96 NG/DL (FROM SN: (B)(6)). THE SAMPLE WAS TESTED FURTHER WITH SIEMENS ATELLICA AND GENERATED THE RESULTS OF 1.54 NG/DL & 1.31 NG/DL. SAMPLE ID (B)(6) (FEMALE, 61 YEARS OLD): ON (B)(6) THE RESULTS WERE 3.16 NG/DL, 1.98 NG/DL, 1.89 NG/DL, 1.40 NG/DL, & 1.32 NG/DL (FROM SN (B)(6)). THE SAMPLE WAS REPEATED ON SN: (B)(6) AND THE RESULTS WERE 1.60 NG/DL, 1.70 NG/DL, 1.76 NG/DL, 1.17 NG/DL, & 1.22 NG/DL. SAMPLE ID (B)(6) (MALE, 73 YEARS OLD): ON (B)(6) THE RESULT WAS 1.99 NG/DL (FROM SN (B)(6)). ON (B)(6) THE SAMPLE WAS REPEATED AND GENERATED THE FOLLOWING RESULTS OF 1.05 NG/DL (FROM SN: (B)(6)), 1.09 NG/DL (FROM SN: (B)(6)), 1.06 NG/DL AND 1.05 NG/DL (FROM SN: (B)(6)).

Additional Manufacturer Narrative

DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. REVIEW OF TRACKING AND TRENDING DATA IDENTIFIED AN INCREASE IN COMPLAINTS FOR THE ALINITY I FREE T4 ASSAY AS WELL AS AN INCREASE IN COMPLAINT ACTIVITY FOR REAGENT LOT 76559UD00. HOWEVER, ACCURACY TESTING WAS PERFORMED UTILIZING RETAINED KITS OF LOT 76559UD00 AND NOTED THAT ALL TESTING PASSED, INDICATING THE REAGENT LOT IS PERFORMING AS EXPECTED. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NONCONFORMANCES, POTENTIAL NONCONFORMANCES OR DEVIATIONS ASSOCIATED WITH LOT NUMBER 76559UD00 AND THE COMPLAINT ISSUE. PER THE LIMITATIONS OF THE PROCEDURE SECTION OF THE PACKAGE INSERT, RESULTS SHOULD BE USED IN CONJUNCTION WITH OTHER DATA, E.G., SYMPTOMS, RESULTS OF OTHER THYROID TESTS, CLINICAL IMPRESSIONS, ETC. IF THE FREE T4 RESULTS ARE INCONSISTENT WITH CLINICAL EVIDENCE, ADDITIONAL TESTING IS SUGGESTED TO CONFIRM THE RESULT. DETAILS AROUND REAGENT AND SPECIMEN HANDLING ARE OUTLINED IN THE PRODUCT PACKAGE INSERT, WHILE THE ALINITY I SYSTEM OPERATIONS MANUAL ALSO PROVIDES INFORMATION REGARDING FURTHER POTENTIAL CAUSES OF ELEVATED RESULTS. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I FREE T4 REAGENT, LOT 76559UD00 WAS IDENTIFIED.