ALINITY I FREE T4 REAGENT KIT

Additional Manufacturer Narrative

AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 07P70-77 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P70-30, 510K K173122.

Description of Event or Problem

THE CUSTOMER OBSERVED A FALSE ELEVATED ALINITY I FREE T4 RESULT GENERATED ON AN ALINITY I PROCESSING MODULE FOR A 45-YEAR-OLD FEMALE PATIENT (SID (B)(6). THE FOLLOWING THYROID FUNCTION RESULTS WERE PROVIDED: FREE T4 = >64.35 PMOL/L, REPEAT RESULT = 11.18 PMOL/L (REFERENCE RANGE 9.01-19.05 PMOL/L) FREE T3 = 4.52 PMOL/L (REFERENCE RANGE 2.43-6.01 PMOL/L) TSH = 5.2026 UIU/ML (REFERENCE RANGE 0.35-4.94 UIU/ML) . THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

Additional Manufacturer Narrative

A COMPLAINT INVESTIGATION WAS CONDUCTED FOR THE ALINITY I FREE T4 REAGENT, LOT 75088UD01. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. A REVIEW OF TRACKING AND TRENDING DID IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY FOR THE ALINITY I FREE T4 ASSAY; HOWEVER, NO COMMONALITIES FOR THE COMPLAINT LOT AND ISSUE WERE IDENTIFIED. IN-HOUSE ACCURACY TESTING WAS PERFORMED UTILIZING RETAINED KITS OF LOT 75088UD01 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 COMPLAINT LOT NUMBER AND 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. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I FREE T4 REAGENT, LOT 75088UD01 WAS IDENTIFIED.

Description of Event or Problem

THE CUSTOMER OBSERVED A FALSE ELEVATED ALINITY I FREE T4 RESULT GENERATED ON AN ALINITY I PROCESSING MODULE FOR A 45-YEAR-OLD FEMALE PATIENT (SID (B)(6)). THE FOLLOWING THYROID FUNCTION RESULTS WERE PROVIDED: FREE T4 = >64.35 PMOL/L, REPEAT RESULT = 11.18 PMOL/L (REFERENCE RANGE 9.01-19.05 PMOL/L). FREE T3 = 4.52 PMOL/L (REFERENCE RANGE 2.43-6.01 PMOL/L). TSH = 5.2026 UIU/ML (REFERENCE RANGE 0.35-4.94 UIU/ML). THERE WAS NO IMPACT TO PATIENT MANAGEMENT.