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	03/04/2026
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.Section a patient information: refer to section b5 for complete patient information.
Event or Problem Description
The customer reported falsely elevated alinity i free t4 results generated on the alinity i processing module for an 84-year-old female taking warfarin diagnosed with heart failure.The following data was provided: on (b)(6) 2026, sid (b)(6) (free t4 normal range: 0.70 to 1.48 ng/dl): ft4 result serum sample = 1.88 ng/dl (result being questioned) repeat testing after re-centrifuging serum sample: ft4 result = 1.39 ng/dl edta-k2 plasma sample: ft4 result = 1.27 ng/dl.Other testing provided by the customer: tsh result = 0.8232 uiu/ml t3 result = < 0.40 ng/ml bnp result = 395 pg/ml repeat testing after re-centrifuging serum sample: tsh result = 0.8047 uiu/ml t3 result = 0.40 ng/ml edta-k2 plasma sample: tsh result = 0.83 uiu/ml.T3 result = < 0.40 ng/ml.The customer stated they are only questioning the free t4 results.No impact to patient management was reported.
Event or Problem Description
The customer reported falsely elevated alinity i free t4 results generated on the alinity i processing module for an 84-year-old female taking warfarin diagnosed with heart failure.The following data was provided: (b)(6) 2026, sid (b)(6) (free t4 normal range: 0.70 to 1.48 ng/dl): ft4 result serum sample = 1.88 ng/dl (result being questioned) repeat testing after re-centrifuging serum sample: ft4 result = 1.39 ng/dl edta-k2 plasma sample: ft4 result = 1.27 ng/dl.Other testing provided by the customer: tsh result = 0.8232 uiu/ml, t3 result = < 0.40 ng/ml, bnp result = 395 pg/ml.Repeat testing after re-centrifuging serum sample: tsh result = 0.8047 uiu/ml, t3 result = 0.40 ng/ml, edta-k2 plasma sample: tsh result = 0.83 uiu/ml, t3 result = < 0.40 ng/ml.The customer stated they are only questioning the free t4 results.No impact to patient management was reported.
Additional Manufacturer Narrative
The data and information provided by the customer were reviewed and support the complaint issue.A review of tracking and trending identified an increase in complaint activity for the alinity i free t4 assay (list number 07p70); however, no trends were identified for the complaint lot.The overall performance of the alinity i free t4 reagents in the field was reviewed using data gathered from customers worldwide.The median population result for the complaint lot 78124ud00 is within established limits, indicating that the lot is performing acceptably in the field.A review of the device history record did not identify any non-conformances, potential nonconformances or deviations associated with lot number 78124ud00 and the complaint issue.A review of labeling was performed and found to sufficiently address the customer's issue.Based on this investigation, no systemic issue or deficiency was identified with the alinity i free t4 reagent, lot number 78124ud00.

• 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: 24685492
• Report Number: 3005094123-2026-00139
• Device Sequence Number: 21245871
• Product Code: CEC
• UDI-Device Identifier: 00380740121815
• UDI-Public: (01)00380740121815(17)260710(10)78124UD00
• 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
• Report Date (Section B): 05/07/2026

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: 07/10/2026
• Device Catalogue Number: 07P70-20
• Device Lot Number: 78124UD00
• 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: 03/05/2026
• Supplement Date Received by Manufacturer: 05/06/2026
• Initial Report FDA Received Date: 03/25/2026
• Supplement Report FDA Received Date: 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2025
• 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)
• Patient Age: 84 YR
• Patient Sex: Female