MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ALINITY I FREE T4 REAGENT KIT; RADIOIMMUNOASSAY, FREE THYROXINE

Catalog Number	07P70-20
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2024
Type of Reportable Event	Malfunction
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.Additional information for section h10 related report numbers: 3005094123-2025-00476, 3005094123-2025-00477, 3005094123-2025-00480, 3005094123-2025-00481.
Event or Problem Description
The customer reported falsely elevated alinity i free t4 results for multiple patient samples.The following data was provided (package insert reference range used by the customer is 0.70 to 1.48 ng/dl): (b)(6) 2024: initial result = 2.45 ng/dl, repeat = 1.07 ng/dl, (b)(6): initial result was >5 ng/dl, repeat = >5 ng/dl, repeat on (b)(6) = 0.92 ng/dl, (b)(6): initial result = 2.2 ng/dl, repeat = 1.22 ng/dl, (b)(6): initial result = 1.53 ng/dl, repeat = 1.34 ng/dl, (b)(6): initial result was >5 ng/dl, repeat = 1.11 ng/dl, (b)(6) 2025: initial result = 1.64 ng/dl, repeat = 1.09 ng/dl, (b)(6): initial result = 2.17 ng/dl, repeat = 1.35 ng/dl, (b)(6): initial result = 5 ng/dl, repeat = 3.77 ng/dl, (b)(6) (second): initial result = 1.94 ng/dl, repeat = 1.20 ng/dl, (b)(6): initial result = 1.50 ng/dl, repeat = 1.33 ng/dl, (b)(6): initial result was >5 ng/dl, repeat = 1.36 ng/dl, (b)(6): initial result = 1.69 ng/dl, repeat = 1.43 ng/dl, (b)(6): initial result was >5 ng/dl, repeat = 1.76 ng/dl, (b)(6): initial result = 1.72 ng/dl, repeat = 1.46 ng/dl, (b)(6): initial result = 1.62 ng/dl, repeat = 1.13 ng/dl, (b)(6): initial result = 1.52 ng/dl, repeat = 1.11 ng/dl, (b)(6): initial result = 1.92 ng/dl, repeat = 1.14 ng/dl, (b)(6): initial result = 1.65 ng/dl, repeat = 1.42 ng/dl, (b)(6): initial result = 1.73 ng/dl, repeat = 1.27 ng/dl.No impact to patient management was reported.
Additional Manufacturer Narrative
Data and information provided by the customer were reviewed and support the complaint issue.Review of tracking and trending data identified an increase in complaints for the architect free t4 assay as well as an increase in complaint activity for the complaint lots.However, testing was performed utilizing retained kits of the complaint lots and noted that all testing passed, indicating the reagent lots are performing as expected.Device history review did not identify any related nonconformances or deviations associated with the architect free t4 assay and complaint issue.Labeling was reviewed which adequately addresses the current issue.Based on the investigation, no systemic issue or deficiency of the architect free t4 assay, lots 8901ud00, 68517ud00, 65267ud00, 71236ud00 and 73276ud00 were identified.
Event or Problem Description
The customer reported falsely elevated alinity i free t4 results for multiple patient samples.The following data was provided (package insert reference range used by the customer is 0.70 to 1.48 ng/dl): (b)(6) 2024: initial result = 2.45 ng/dl, repeat = 1.07 ng/dl, (b)(6): initial result was >5 ng/dl, repeat = >5 ng/dl, repeat on (b)(6) = 0.92 ng/dl, (b)(6): initial result = 2.2 ng/dl, repeat = 1.22 ng/dl, (b)(6): initial result = 1.53 ng/dl, repeat = 1.34 ng/dl, (b)(6): initial result was >5 ng/dl, repeat = 1.11 ng/dl, (b)(6) 2025: initial result = 1.64 ng/dl, repeat = 1.09 ng/dl, (b)(6): initial result = 2.17 ng/dl, repeat = 1.35 ng/dl, (b)(6): initial result = 5 ng/dl, repeat = 3.77 ng/dl, (b)(6) (second): initial result = 1.94 ng/dl, repeat = 1.20 ng/dl, (b)(6): initial result = 1.50 ng/dl, repeat = 1.33 ng/dl, (b)(6): initial result was >5 ng/dl, repeat = 1.36 ng/dl, (b)(6): initial result = 1.69 ng/dl, repeat = 1.43 ng/dl, (b)(6): initial result was >5 ng/dl, repeat = 1.76 ng/dl, (b)(6): initial result = 1.72 ng/dl, repeat = 1.46 ng/dl, (b)(6): initial result = 1.62 ng/dl, repeat = 1.13 ng/dl, (b)(6): initial result = 1.52 ng/dl, repeat = 1.11 ng/dl, (b)(6): initial result = 1.92 ng/dl, repeat = 1.14 ng/dl, (b)(6): initial result = 1.65 ng/dl, repeat = 1.42 ng/dl, (b)(6): initial result = 1.73 ng/dl, repeat = 1.27 ng/dl.No impact to patient management was reported.

• Brand Name: ALINITY I FREE T4 REAGENT KIT
• Common Device Name: RADIOIMMUNOASSAY, FREE THYROXINE
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer (Section G): ABBOTT IRELAND DIAGNOSTICS DIVISION; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 23154199
• Report Number: 3005094123-2025-00478
• Device Sequence Number: 15978081
• Product Code: CEC
• UDI-Device Identifier: 00380740121815
• UDI-Public: (01)00380740121815(17)251009(10)68517UD00
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K173122
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/09/2025
• Device Catalogue Number: 07P70-20
• Device Lot Number: 68517UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2025
• Supplement Date Received by Manufacturer: 11/26/2025
• Initial Report FDA Received Date: 09/26/2025
• Supplement Report FDA Received Date: 12/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALIN I FREE T4 RGT 200T, 07P70-20, 65267UD00,; ALIN I FREE T4 RGT 200T, 07P70-20, 65267UD00,; ALIN I FREE T4 RGT 200T, 07P70-20, 68901UD00,; ALIN I FREE T4 RGT 200T, 07P70-20, 68901UD00,; ALIN I FREE T4 RGT 200T, 07P70-20, 71236UD00,; ALIN I FREE T4 RGT 200T, 07P70-20, 71236UD00,; ALIN I FREE T4 RGT 200T, 07P70-20, 73276UD00,; ALIN I FREE T4 RGT 200T, 07P70-20, 73276UD00.; ALNTY I PROCESSING MODU, 03R65-01, (B)(6),; ALNTY I PROCESSING MODU, 03R65-01, (B)(6),
• Patient Sex: Unknown