ALINITY I FREE T4 REAGENT KIT

Description of Event or Problem

THE CUSTOMER REPORTED FALSE ELEVATED ALINITY I FREE T4 AND PROVIDED THE FOLLOWING DATA: ON (B)(6) 2025 INITIAL RESULT WAS > 5.0 NG/DL. ON (B)(6) 2025 INITIAL RESULT WAS > 5.0 NG/DL. ON (B)(6) 2025 INITIAL RESULT WAS 1.33 NG/DL. ON (B)(6) 2025 INITIAL RESULT WAS > 5.0 NG/DL. ON (B)(6) 2025, SAMPLE ID: (B)(6) INITIAL RESULT WAS > 5.0 NG/DL AND RETEST RESULT WAS 1.32 NG/DL FREE T4 WAS MEASURED AT ANOTHER INSTITUTION ON THE COBAS PLATFORM, AND THE RESULT WAS WITHIN THE REFERENCE RANGE. ADDITIONALLY, CUSTOMER REPORTED ABNORMAL FINDINGS IN THE TEST RESULTS FOR BIOCHEMISTRY, BLOOD COUNTS, OR THYROID AUTOANTIBODIES, ETC. PATIENT INFORMATION: 77-YEAR-OLD MALE. MEDICAL HISTORY: COLON EMR, ATRIAL FIBRILLATION, HYPERTENSION, DIABETES. MEDICATION: MERCAZOLE, IODINE, AMLODOPINE, ONGLYZA, LIXIANA, ASTOMIN (MMT IS CURRENTLY ON PAUSE). THE CUSTOMER REPORTED THAT THE PATIENT HAS BEEN RECEIVING TREATMENT (DETAILS NOT PROVIDED) AND THE CUSTOMER DOESN'T FEEL THAT THE TREATMENT THE PATIENT HAS BEEN RECEIVING HAS BEEN UNNECESSARY. OTHER THYROID TEST RESULTS (E.G., TSH): WITHIN REFERENCE RANGE THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

Additional Manufacturer Narrative

AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

Additional Manufacturer Narrative

THE 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 TRENDS WERE IDENTIFIED FOR THE COMPLAINT LOT. IN-HOUSE TESTING WITH A RETAINED KIT OF REAGENT LOT 73276UD00 WAS COMPLETED. TESTING MET ACCEPTANCE CRITERIA, AND THE PRODUCT IS PERFORMING AS EXPECTED. DEVICE HISTORY REVIEW DID NOT IDENTIFY ANY NONCONFORMANCES, POTENTIAL NONCONFORMANCES OR DEVIATIONS ASSOCIATED WITH THE COMPLAINT LOT AND COMPLAINT ISSUE. LABELING WAS REVIEWED WHICH ADEQUATELY ADDRESSES THE CURRENT ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WITH THE ALINITY I FREE T4 ASSAY, LOT 73276UD00 WAS IDENTIFIED.

Description of Event or Problem

THE CUSTOMER REPORTED FALSE ELEVATED ALINITY I FREE T4 AND PROVIDED THE FOLLOWING DATA: ON (B)(6) 2025 INITIAL RESULT WAS > 5.0 NG/DL, ON (B)(6) 2025 INITIAL RESULT WAS > 5.0 NG/DL, ON (B)(6) 2025 INITIAL RESULT WAS 1.33 NG/DL, ON (B)(6) 2025 INITIAL RESULT WAS > 5.0 NG/DL. ON (B)(6) 2025, SAMPLE ID (B)(6), INITIAL RESULT WAS > 5.0 NG/DL AND RETEST RESULT WAS 1.32 NG/DL. FREE T4 WAS MEASURED AT ANOTHER INSTITUTION ON THE COBAS PLATFORM, AND THE RESULT WAS WITHIN THE REFERENCE RANGE. ADDITIONALLY, CUSTOMER REPORTED ABNORMAL FINDINGS IN THE TEST RESULTS FOR BIOCHEMISTRY, BLOOD COUNTS, OR THYROID AUTOANTIBODIES, ETC. PATIENT INFORMATION: 77-YEAR-OLD MALE MEDICAL HISTORY: COLON EMR, ATRIAL FIBRILLATION, HYPERTENSION, DIABETES MEDICATION: MERCAZOLE, IODINE, AMLODOPINE, ONGLYZA, LIXIANA, ASTOMIN (MMT IS CURRENTLY ON PAUSE) THE CUSTOMER REPORTED THAT THE PATIENT HAS BEEN RECEIVING TREATMENT (DETAILS NOT PROVIDED) AND THE CUSTOMER DOESN'T FEEL THAT THE TREATMENT THE PATIENT HAS BEEN RECEIVING HAS BEEN UNNECESSARY. OTHER THYROID TEST RESULTS (E.G., TSH): WITHIN REFERENCE RANGE THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT. UPDATE: THE CUSTOMER SENT THE SAMPLE OUT FOR ADDITIONAL TESTING AND REPORTED THE TEST RESULTS WERE SIMILAR TO THE RETEST RESULTS (I.E. 1.32 NG/DL) OBTAINED AT THE CUSTOMER SITE.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION CAN BE FOUND IN SECTION B5.

Description of Event or Problem

THE CUSTOMER REPORTED FALSE ELEVATED ALINITY I FREE T4 AND PROVIDED THE FOLLOWING DATA: ON (B)(6)2025, INITIAL RESULT WAS > 5.0 NG/DL, ON (B)(6) 2025, INITIAL RESULT WAS > 5.0 NG/DL, ON (B)(6) 2025, INITIAL RESULT WAS 1.33 NG/DL, ON (B)(6) 2025, INITIAL RESULT WAS > 5.0 NG/DL, ON (B)(6) 2025, SAMPLE ID 73726UD00 INITIAL RESULT WAS > 5.0 NG/DL AND RETEST RESULT WAS 1.32 NG/DL. FREE T4 WAS MEASURED AT ANOTHER INSTITUTION ON THE COBAS PLATFORM, AND THE RESULT WAS WITHIN THE REFERENCE RANGE. ADDITIONALLY, CUSTOMER REPORTED ABNORMAL FINDINGS IN THE TEST RESULTS FOR BIOCHEMISTRY, BLOOD COUNTS, OR THYROID AUTOANTIBODIES, ETC. PATIENT INFORMATION: 77-YEAR-OLD MALE MEDICAL HISTORY: COLON EMR, ATRIAL FIBRILLATION, HYPERTENSION, DIABETES MEDICATION: MERCAZOLE, IODINE, AMLODOPINE, ONGLYZA, LIXIANA, ASTOMIN (MMT IS CURRENTLY ON PAUSE) THE CUSTOMER REPORTED THAT THE PATIENT HAS BEEN RECEIVING TREATMENT (DETAILS NOT PROVIDED) AND THE CUSTOMER DOESN'T FEEL THAT THE TREATMENT THE PATIENT HAS BEEN RECEIVING HAS BEEN UNNECESSARY. OTHER THYROID TEST RESULTS (E.G., TSH): WITHIN REFERENCE RANGE THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT. UPDATE: THE CUSTOMER SENT THE SAMPLE OUT FOR ADDITIONAL TESTING AND REPORTED THE TEST RESULTS WERE SIMILAR TO THE RETEST RESULTS (I.E. 1.32 NG/DL) OBTAINED AT THE CUSTOMER SITE.