ALINITY I FREE T4 REAGENT KIT

Description of Event or Problem

THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY I FREE T4 (FT4) RESULTS FOR MULTIPLE PATIENTS. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S NORMAL RANGE: </= 25 PMOL/L): ON (B)(6) 2025: PID (B)(6): INITIAL FT4 RESULT = 30.5 PMOL/L (RAN ON AI25005); REPEATED ON ANOTHER ANALYZER (AI03367) = 22.10 PMOL/L. PID (B)(6): INITIAL FT4 RESULT = 30.88 PMOL/L; REPEATED ON ANOTHER ANALYZER (AI25554) = 16.48 PMOL/L. PID (B)(6): INITIAL FT4 RESULT = 17.68 PMOL/L; REPEATED ON ANOTHER ANALYZER (AI25554) = 35.65 PMOL/L. 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. A1 - PATIENT IDENTIFIER: (B)(6) (3 TOTAL PATIENTS). ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. E1 - POSTAL CODE: A LEADING ZERO WAS ADDED TO THE FIELD BECAUSE THE SYSTEM REQUIRES A MINIMUM OF 5 DIGITS IN THE POSTAL CODE FIELD.

Additional Manufacturer Narrative

THE COMPLAINT INVESTIGATION 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 IN-HOUSE TESTING OF A RETAINED KIT OF THE COMPLAINT LOT. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. A SEARCH FOR SIMILAR COMPLAINTS IDENTIFIED AN INCREASE IN COMPLAINT ACTIVITY FOR LOT 73465UD00, HOWEVER, NO INCREASE IN COMPLAINT ACTIVITY WAS IDENTIFIED FOR LIST NUMBER 07P70. ADDITIONALLY, IN-HOUSE PERFORMANCE TESTING WAS COMPLETED USING A RETAINED KIT OF THE COMPLAINT LOT 73465UD00. TESTING MET ACCEPTANCE CRITERIA, AND THE PRODUCT IS PERFORMING AS EXPECTED. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT IDENTIFY ANY NONCONFORMANCES OR DEVIATIONS ASSOCIATED WITH THE COMPLAINT LOT. LABELING WAS REVIEWED AND ADEQUATELY ADDRESSES THE CURRENT ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY OF THE ALINITY I FREE T4 REAGENT LOT 73465UD00 WAS IDENTIFIED.

Description of Event or Problem

THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY I FREE T4 (FT4) RESULTS FOR MULTIPLE PATIENTS. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S NORMAL RANGE: </= 25 PMOL/L): ON (B)(6) 2025: PID (B)(6): INITIAL FT4 RESULT = 30.5 PMOL/L (RAN ON (B)(6); REPEATED ON ANOTHER ANALYZER (B)(6) = 22.10 PMOL/L. PID (B)(6): INITIAL FT4 RESULT = 30.88 PMOL/L; REPEATED ON ANOTHER ANALYZER (B)(6) = 16.48 PMOL/L. PID (B)(6): INITIAL FT4 RESULT = 17.68 PMOL/L; REPEATED ON ANOTHER ANALYZER (B)6) = 35.65 PMOL/L. NEW PATIENT INFORMATION RECEIVED BY THE CUSTOMER ON (B)(6) 2025, STATING THE ALINITY I FREE T4 INITIAL RESULTS ARE APPROXIMATELY ABOVE 30 PMOL/L AND WHEN RETESTED THE RESULTS WERE NORMAL. THE FOLLOWING PATIENT RESULTS WERE PROVIDED (CUSTOMER¿S NORMAL RANGE: </= 25 PMOL/L): ON (B)(6) 2025, PID (B)(6). INITIAL FT4 RESULT ON (B)(6) AT 2:36 PM = 26.77 PMOL/L. REPEAT RESULT ON (B)(6) AT 3:32 PM = 18.69 PMOL/L. ON (B)(6) 2025, PID (B)(6) INITIAL FT4 RESULT ON (B)(6) AT 2:06 PM = 28.98 PMOL/L. REPEAT RESULT ON (B)(6) AT 2:49 PM = 22.12 PMOL/L. ON (B)(6) 2025, PID (B)(6) INITIAL FT4 RESULT ON (B)(6) AT 8:35 AM = 28.54 PMOL/L. REPEAT RESULT ON (B)(6) AT 9:37 AM = 25.04 PMOL/L. ON (B)(6) 2025, PID (B)(6): (B)(6), (B)(6) 2025 10:38 AM 21.40 PMOL/L, INITIAL FT4 RESULT ON (B)(6) AT 8:54 AM = 31.61 PMOL/L, ASPIRATION ERROR OCCURRED ON (B)(6) AT 10:00 AM = NO RESULT PROVIDED, REPEAT RESULT ON (B)(6) AT 10:38 AM = 21.40 PMOL/L. ADDITIONAL PATIENT INFORMATION WAS PROVIDED BY THE CUSTOMER FOR FALSELY ELEVATED ALINITY I FREE T4 RESULTS ON (B)(6) 2025. THE FOLLOWING INFORMATION WAS PROVIDED (CUSTOMER'S NORMAL RANGE: </= 25 PMOL/L): SID (B)(6) : FIRST RESULT = 28.5 PMOL/L / SECOND RESULT = 25 PMOLL, SID (B)(6) : FIRST RESULT = 29 PMOL/L / SECOND RESULT = 22.1 PMOL/L, SID (B)(6): FIRST RESULT = 26.8 PMOL/L / SECOND RESULT =18.7 PMOL/L, SID (B)(6) : FIRST RESULT = 31.6 PMOL/L / SECOND RESULT = 21.4 PMOL/L, SID (B)(6): FIRST RESULT = >64.35 PMOL/L / SECOND RESULT = 18.9 PMOL/L, SID (B)(6) : FIRST RESULT = 40.1 PMOL/L / SECOND RESULT = 23.3 PMOL/L. ADDITIONAL PATIENT DATA WAS PROVIDED BY THE CUSTOMER FOR FALSELY ELEVATED ALINITY I FREE T4 RESULTS ON (B)(6) 2025. THE FOLLOWING INFORMATION WAS PROVIDED (CUSTOMER¿S NORMAL RANGE: </= 25 PMOL/L): SID (B)(6) : FIRST RESULT = 25.80 PMOL/L / SECOND RESULT = 13.70 PMOL/L, SID (B)(6) : FIRST RESULT = 27.80 PMOL/L / SECOND RESULT = 21.70 PMOL/L, SID (B)(6) : FIRST RESULT = 26.10 PMOL/L / SECOND RESULT = 22.80 PMOL/L, SID (B)(6) : FIRST RESULT = 29.00 PMOL/L / SECOND RESULT = 20.00 PMOL/L, SID (B)(6) : FIRST RESULT = 30.20 PMOL/L / SECOND RESULT = 16.70 PMOL/L, SID (B)(6) : FIRST RESULT = 64.35 PMOL/L / SECOND RESULT = 22.70 PMOL/L, SID (B)(6): FIRST RESULT = 27.70 PMOL/L / SECOND RESULT = 23.20 PMOL/L, SID (B)(6): FIRST RESULT = 26.30 PMOL/L / SECOND RESULT = 16.30 PMOL/L, SID (B)(6): FIRST RESULT = 26.30 PMOL/L / SECOND RESULT = 20.70 PMOL/L. 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. UPDATED A1 - PATIENT IDENTIFIER TO ADD ADDITIONAL PATIENT IDS: INITIAL IDS = (B)(6). ADDITIONAL PATIENT IDS = (B)(6) (THIS MAKES IT A TOTAL OF 7 PATIENTS). ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. ADDITIONAL INFORMATION ADDED TO B5 - DESCRIBE EVENT OR PROBLEM E1 - POSTAL CODE: A LEADING ZERO WAS ADDED TO THE FIELD BECAUSE THE SYSTEM REQUIRES A MINIMUM OF 5 DIGITS IN THE POSTAL CODE FIELD.

Description of Event or Problem

NEW PATIENT INFORMATION RECEIVED BY THE CUSTOMER ON 17JUL2025, STATING THE ALINITY I FREE T4 INITIAL RESULTS ARE APPROXIMATELY ABOVE 30 PMOL/L AND WHEN RETESTED THE RESULTS WERE NORMAL. THE FOLLOWING PATIENT RESULTS WERE PROVIDED (CUSTOMER¿S NORMAL RANGE: </= 25 PMOL/L): ON (B)(6) 2025, PID (B)(6). INITIAL FT4 RESULT ON (B)(6) AT 2:36 PM = 26.77 PMOL/L. REPEAT RESULT ON (B)(6) AT 3:32 PM = 18.69 PMOL/L. ON (B)(6) 2025, PID (B)(6). INITIAL FT4 RESULT ON (B)(6) AT 2:06 PM = 28.98 PMOL/L. REPEAT RESULT ON (B)(6) AT 2:49 PM = 22.12 PMOL/L. ON (B)(6) 2025, PID (B)(6) INITIAL FT4 RESULT ON (B)(6) AT 8:35 AM = 28.54 PMOL/L. REPEAT RESULT ON (B)(6) AT 9:37 AM = 25.04 PMOL/L. ON (B)(6) 2025, PID (B)(6): (B)(6), ON (B)(6) 2025 10:38 AM 21.40 PMOL/L. INITIAL FT4 RESULT ON (B)(6) AT 8:54 AM = 31.61 PMOL/L. ASPIRATION ERROR OCCURRED ON AI25554 AT 10:00 AM = NO RESULT PROVIDED. REPEAT RESULT ON (B)(6) AT 10:38 AM = 21.40 PMOL/L. 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. UPDATED A1 - PATIENT IDENTIFIER TO ADD ADDITIONAL PATIENT IDS: ADDITIONAL PATIENT IDS = (B)(6) (6 ADDITIONAL SAMPLE IDS FOR A TOTAL OF 13 PATIENTS ALL TOGETHER) ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. ADDITIONAL PATIENT INFORMATION ADDED TO B5 - DESCRIBE EVENT OR PROBLEM. E1 - POSTAL CODE: A LEADING ZERO WAS ADDED TO THE FIELD BECAUSE THE SYSTEM REQUIRES A MINIMUM OF 5 DIGITS IN THE POSTAL CODE FIELD.

Description of Event or Problem

UPDATE: ADDITIONAL PATIENT INFORMATION WAS PROVIDED BY THE CUSTOMER FOR FALSELY ELEVATED ALINITY I FREE T4 REUSLTS ON 25JUL2025. THE FOLLOWING INFORMATION WAS PROVIDED (CUSTOMER'S NORMAL RANGE: </= 25 PMOL/L): SID (B)(6): FIRST RESULT = 28.5 PMOL/L / SECOND RESULT = 25 PMOLL. SID (B)(6): FIRST RESULT = 29 PMOL/L / SECOND RESULT = 22.1 PMOL/L. SID (B)(6): FIRST RESULT = 26.8 PMOL/L / SECOND RESULT =18.7 PMOL/L. SID (B)(6): FIRST RESULT = 31.6 PMOL/L / SECOND RESULT = 21.4 PMOL/L. SID (B)(6): FIRST RESULT = >64.35 PMOL/L / SECOND RESULT = 18.9. SID (B)(6) FIRST RESULT = 40.1 PMOL/L / SECOND RESULT = 23.3 PMOL/L. 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. UPDATED A1 - PATIENT IDENTIFIER TO ADD ADDITIONAL PATIENT IDS: ADDITIONAL PATIENT IDS = (B)(6) (9 ADDITIONAL SAMPLE IDS FOR A TOTAL OF 22 PATIENTS ALL TOGETHER). ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. ADDITIONAL PATIENT INFORMATION ADDED TO B5 - DESCRIBE EVENT OR PROBLEM. E1 - POSTAL CODE: A LEADING ZERO WAS ADDED TO THE FIELD BECAUSE THE SYSTEM REQUIRES A MINIMUM OF 5 DIGITS IN THE POSTAL CODE FIELD.

Description of Event or Problem

ADDITIONAL PATIENT DATA WAS PROVIDED BY THE CUSTOMER FOR FALSELY ELEVATED ALINITY I FREE T4 RESULTS ON (B)(6) 2025. THE FOLLOWING INFORMATION WAS PROVIDED (CUSTOMER¿S NORMAL RANGE: </= 25 PMOL/L): SID (B)(6): FIRST RESULT = 25.80 PMOL/L / SECOND RESULT = 13.70 PMOL/L. SID (B)(6): FIRST RESULT = 27.80 PMOL/L / SECOND RESULT = 21.70 PMOL/L. SID (B)(6): FIRST RESULT = 26.10 PMOL/L / SECOND RESULT = 22.80 PMOL/L. SID (B)(6): FIRST RESULT = 29.00 PMOL/L / SECOND RESULT = 20.00 PMOL/L. SID (B)(6): FIRST RESULT = 30.20 PMOL/L / SECOND RESULT = 16.70 PMOL/L. SID (B)(6): FIRST RESULT = 64.35 PMOL/L / SECOND RESULT = 22.70 PMOL/L. SID (B)(6): FIRST RESULT = 27.70 PMOL/L / SECOND RESULT = 23.20 PMOL/L. SID (B)(6): FIRST RESULT = 26.30 PMOL/L / SECOND RESULT = 16.30 PMOL/L. SID (B)(6): FIRST RESULT = 26.30 PMOL/L / SECOND RESULT = 20.70 PMOL/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.