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. COMPLETE INFORMATION FROM SECTION A1 PATIENT IDENTIFIER: MULTIPLE = SID (B)(6). ALL AVAILABLE PATIENT INFORMATION HAS BEEN INCLUDED. NO ADDITIONAL PATIENT DETAILS ARE AVAILABLE.

Description of Event or Problem

THE CUSTOMER OBSERVED ERRATIC ALINITY I FREE T4 FOR MULTIPLE PATIENTS. THE CUSTOMER NOTES THAT THE RESULTS WERE WITHIN NORMAL RANGE, BUT LATER THE RESULTS WERE OUT OF REFERENCE RANGE. THE FOLLOWING DATA WAS PROVIDED: REFERENCE RANGES: ADULTS: 0.75 TO 1.22 NG/DL. PEDIATRICS: < 1 MONTH NOT AVAILABLE. 1 TO 23 MONTHS: 0.86 TO 1.32 NG/DL. 2 TO 12 YEARS: 0.84 TO 1.32 NG/DL. 13 TO 18 YEARS: 0.81 TO 1.32 NG/DL. SID (B)(6), 9-YEAR-OLD MALE, INITIAL FREE T4 RESULT= 1.30 NG/DL; REPEAT RESULT= 1.93 NG/DL. SID (B)(6), 39-YEAR-OLD MALE, INITIAL FREE T4 RESULT= 1.06 NG/DL; REPEAT RESULT= 1.30 NG/DL. SID (B)(6), 73-YEAR-OLD MALE, INITIAL FREE T4 RESULT= 1.32 NG/DL; REPEAT RESULT= 1.55 NG/DL. FURTHER TESTING OF THE SAMPLES WAS PERFORMED: SID (B)(6). (B)(6) 2025, ANALYZER (B)(6), FREE T4 RESULT= 1.30 NG/DL. (B)(6) 2025, AFTER HOMOGENIZING THE SAMPLE, ANALYZER (B)(6), RESULT= 1.93 NG/DL; ANALYZER (B)(6), RESULT= 1.96 NG/DL, 1.88 NG/DL, 1.87 NG/DL. (B)(6) 2025, AFTER RECENTRIFUGING THE SAMPLE, ANALYZER (B)(6) RESULT= 1.02 NG/DL; ANALYZER (B)(6) RESULT= 1.06 NG/DL; (B)(6) 2025, ANALYZER (B)(6) RESULT= 1.06 NG/DL. SID (B)(6). (B)(6) 2025, ANALYZER (B)(6), FREE T4 RESULT= 1.06 NG/DL. (B)(6) 2025, AFTER HOMOGENIZING THE SAMPLE, ANALYZER (B)(6) RESULT= 1.30 NG/DL; ANALYZER (B)(6) RESULT= 1.40 NG/DL, 1.34 NG/DL, 1.40 NG/DL. (B)(6) 2025, AFTER RECENTRIFUGING THE SAMPLE, ANALYZER (B)(6) RESULT= 1.00 NG/DL, ANALYZER (B)(6) RESULT= 1.12 NG/DL; (B)(6) 2025, ANALYZER (B)(6) RESULT= 1.09 NG/DL. SID (B)(6). (B)(6) 2025, ANALYZER (B)(6) FREE T4 RESULT= 1.32 NG/DL. (B)(6) 2025, AFTER HOMOGENIZING THE SAMPLE; ANALYZER (B)(6) RESULT= 1.55 NG/DL; ANALYZER (B)(6) RESULT= 1.54 NG/DL, 1.56 NG/DL, 1.52 NG/DL. (B)(6) 2025, AFTER RECENTRIFUGING THE SAMPLE, ANALYZER (B)(6) RESULT= 1.17 NG/DL; ANALYZER (B)(6) RESULT= 1.22 NG/DL, (B)(6) 2025, ANALYZER (B)(6) RESULT= 1.25 NG/DL. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

Additional Manufacturer Narrative

THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, DEVICE HISTORY RECORD REVIEW, IN HOUSE TESTING OF A RETAINED KIT AND LABELING REVIEW. 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 COMPLAINTS FOR LIST NUMBER 07P70, HOWEVER, NO TRENDS WERE IDENTIFIED FOR LOT 76559UD00. A DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NONCONFORMANCES, POTENTIAL NONCONFORMANCES OR DEVIATIONS ASSOCIATED WITH THE COMPLAINT LOT NUMBER AND COMPLAINT ISSUE. IN-HOUSE ACCURACY TESTING WAS COMPLETED WITH A RETAINED KIT OF THE COMPLAINT LOT. ALL VALIDITY AND ACCEPTANCE CRITERIA WERE MET DURING COMPLETION OF THE PROTOCOL, DEMONSTRATING THAT THE LOT IS PERFORMING AS EXPECTED. LABELING WAS REVIEWED WHICH ADEQUATELY ADDRESSES THE CURRENT ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I FREE T4 REAGENT LOT 76559UD00 WAS IDENTIFIED.

Description of Event or Problem

THE CUSTOMER OBSERVED ERRATIC ALINITY I FREE T4 FOR MULTIPLE PATIENTS. THE CUSTOMER NOTES THAT THE RESULTS WERE WITHIN NORMAL RANGE, BUT LATER THE RESULTS WERE OUT OF REFERENCE RANGE. THE FOLLOWING DATA WAS PROVIDED: REFERENCE RANGES: ADULTS: 0.75 TO 1.22 NG/DL. PEDIATRICS: < 1 MONTH NOT AVAILABLE 1 TO 23 MONTHS: 0.86 TO 1.32 NG/DL. 2 TO 12 YEARS: 0.84 TO 1.32 NG/DL. 13 TO 18 YEARS: 0.81 TO 1.32 NG/DL. SID (B)(6), 9-YEAR-OLD MALE, INITIAL FREE T4 RESULT= 1.30 NG/DL; REPEAT RESULT= 1.93 NG/DL. SID (B)(6), 39-YEAR-OLD MALE, INITIAL FREE T4 RESULT= 1.06 NG/DL; REPEAT RESULT= 1.30 NG/DL. SID (B)(6), 73-YEAR-OLD MALE, INITIAL FREE T4 RESULT= 1.32 NG/DL; REPEAT RESULT= 1.55 NG/DL. FURTHER TESTING OF THE SAMPLES WAS PERFORMED: SID (B)(6) (B)(6) 2025, ANALYZER (B)(6), FREE T4 RESULT= 1.30 NG/DL (B)(6) 2025, AFTER HOMOGENIZING THE SAMPLE, ANALYZER (B)(6), RESULT= 1.93 NG/DL; ANALYZER (B)(6), RESULT= 1.96 NG/DL, 1.88 NG/DL, 1.87 NG/DL (B)(6) 2025, AFTER RECENTRIFUGING THE SAMPLE, ANALYZER (B)(6) RESULT= 1.02 NG/DL; ANALYZER (B)(6) RESULT= 1.06 NG/DL; (B)(6) 2025, ANALYZER (B)(6) RESULT= 1.06 NG/DL SID (B)(6) (B)(6) 2025, ANALYZER (B)(6), FREE T4 RESULT= 1.06 NG/DL (B)(6) 2025, AFTER HOMOGENIZING THE SAMPLE, ANALYZER (B)(6) RESULT= 1.30 NG/DL; ANALYZER (B)(6) RESULT= 1.40 NG/DL, 1.34 NG/DL, 1.40 NG/DL (B)(6) 2025, AFTER RECENTRIFUGING THE SAMPLE, ANALYZER (B)(6) RESULT= 1.00 NG/DL, ANALYZER (B)(6) RESULT= 1.12 NG/DL; (B)(6) 2025, ANALYZER (B)(6) RESULT= 1.09 NG/DL. SID (B)(6) (B)(6) 2025, ANALYZER (B)(6) FREE T4 RESULT= 1.32 NG/DL (B)(6) 2025, AFTER HOMOGENIZING THE SAMPLE; ANALYZER (B)(6) RESULT= 1.55 NG/DL; ANALYZER (B)(6) RESULT= 1.54 NG/DL, 1.56 NG/DL, 1.52 NG/DL (B)(6) 2025, AFTER RECENTRIFUGING THE SAMPLE, ANALYZER (B)(6) RESULT= 1.17 NG/DL; ANALYZER (B)(6) 7 RESULT= 1.22 NG/DL, (B)(6) 2025, ANALYZER (B)(6) RESULT= 1.25 NG/DL. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.