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	02/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
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
Additional information can be found in section b5.
Event or Problem Description
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.
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.
Event or Problem Description
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.

• 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: 23284622
• Report Number: 3005094123-2025-00511
• Device Sequence Number: 15642015
• Product Code: CEC
• UDI-Device Identifier: 00380740121815
• UDI-Public: (01)00380740121815(17)260205(10)73276UD00
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/19/2025

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: 02/05/2026
• Device Catalogue Number: 07P70-20
• Device Lot Number: 73276UD00
• 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: 09/29/2025
• Supplement Date Received by Manufacturer: 10/22/2025; 12/17/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 10/23/2025; 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/24/2025
• 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: ALNTY I PROCESSING MODU, 03R65-01, (B)(6); ALNTY I PROCESSING MODU, 03R65-01, (B)(6); ALNTY I PROCESSING MODU, 03R65-01, (B)(6)
• Patient Age: 77 YR
• Patient Sex: Male