ALINITY I FREE T4 REAGENT KIT

Description of Event or Problem

THE CUSTOMER REPORTED A FALSELY DECREASED ALINITY I FREE T4 RESULTS GENERATED ON THE ALINITY I PROCESSING MODULE FOR A 10-YEAR-OLD FEMALE DIAGNOSED WITH HYPERTHYROIDISM. THE FOLLOWING DATA WAS PROVIDED: ON (B)(6) 2025, PATIENT (10-YEAR-OLD, FEMALE): ABBOTT FT4 RESULT = 20.3 / 22.95 PMOL/L (ABBOTT REFERENCE RANGE 9.0-25.7 PMOL/L), MINDRAY FT4 RESULT = 39.24 PMOL/L (MINDRAY REFERENCE RANGE: 10.16-24.34 PMOL/L). OTHER LABORATORY TESTING PROVIDED: ABBOTT FT3 RESULT = 12.9 PMOL/L (ABBOTT REFERENCE RANGE: 3.7-8.6 PMOL/L), MINDRAY FT3 RESULT = 14.83 PMOL/L (MINDRAY REFERENCE RANGE: 3.77-6.8 PMOL/L). ABBOTT T3 RESULT = 3.8 NMOL/L (ABBOTT REFERENCE RANGE: 1.4-3.6 NMOL/L), MINDRAY T3 RESULT = 3.74 NMOL/L (MINDRAY REFERENCE RANGE: 1.22-2.38 NMOL/L). ABBOTT TT4 RESULT = 171 NMOL/L (ABBOTT REFERENCE RANGE: 58-129 NMOL/L), MINDRAY TT4 RESULT = 176.95 NMOL/L (MINDRAY REFERENCE RANGE: 63.29-146.94 NMOL/L). ABBOTT TSH RESULT = 0 MIU/L (ABBOTT REFERENCE RANGE: 0.5-4.5 MIU/L), MINDRAY TSH RESULT = 0.01 MIU/L (MINDRAY REFERENCE RANGE: 0.83-7.42 MIU/L). ABBOTT ANTI-TPO RESULT = 173 IU/ML (REFERENCE RANGE: 0-6 IU/ML), ABBOTT ANTI-TG RESULT = 777 IU/ML (REFERENCE RANGE: 0-4 IU/ML), ABBOTT TRAB RESULT = 27.86 IU/ML (REFERENCE RANGE: 0-2.58 IU/ML) . THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

Additional Manufacturer Narrative

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. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 07P70-77 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 07P70, WITH 510K/PMA/BLA NUMBER K173122.

Additional Manufacturer Narrative

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 LOT NUMBER 75088UD01 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. 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 REPORTED A FALSELY DECREASED ALINITY I FREE T4 RESULTS GENERATED ON THE ALINITY I PROCESSING MODULE FOR A 10-YEAR-OLD FEMALE DIAGNOSED WITH HYPERTHYROIDISM. THE FOLLOWING DATA WAS PROVIDED: ON (B)(6) 2025, PATIENT (10-YEAR-OLD, FEMALE): ABBOTT FT4 RESULT = 20.3 / 22.95 PMOL/L (ABBOTT REFERENCE RANGE 9.0-25.7 PMOL/L), MINDRAY FT4 RESULT = 39.24 PMOL/L (MINDRAY REFERENCE RANGE: 10.16-24.34 PMOL/L). OTHER LABORATORY TESTING PROVIDED: ABBOTT FT3 RESULT = 12.9 PMOL/L (ABBOTT REFERENCE RANGE: 3.7-8.6 PMOL/L), MINDRAY FT3 RESULT = 14.83 PMOL/L (MINDRAY REFERENCE RANGE: 3.77-6.8 PMOL/L). ABBOTT T3 RESULT = 3.8 NMOL/L (ABBOTT REFERENCE RANGE: 1.4-3.6 NMOL/L), MINDRAY T3 RESULT = 3.74 NMOL/L (MINDRAY REFERENCE RANGE: 1.22-2.38 NMOL/L). ABBOTT TT4 RESULT = 171 NMOL/L (ABBOTT REFERENCE RANGE: 58-129 NMOL/L), MINDRAY TT4 RESULT = 176.95 NMOL/L (MINDRAY REFERENCE RANGE: 63.29-146.94 NMOL/L). ABBOTT TSH RESULT = 0 MIU/L (ABBOTT REFERENCE RANGE: 0.5-4.5 MIU/L), MINDRAY TSH RESULT = 0.01 MIU/L (MINDRAY REFERENCE RANGE: 0.83-7.42 MIU/L). ABBOTT ANTI-TPO RESULT = 173 IU/ML (REFERENCE RANGE: 0-6 IU/ML), ABBOTT ANTI-TG RESULT = 777 IU/ML (REFERENCE RANGE: 0-4 IU/ML), ABBOTT TRAB RESULT = 27.86 IU/ML (REFERENCE RANGE: 0-2.58 IU/ML). THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.