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	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed erratic alinity i free t4 for multiple patients.The following results were provided (reference range 9 - 19 pmol/l): on (b)(6) 2025, sid (b)(6), initial ft4 result (b)(6) = 7.8 pmol/l; repeat result= 11.7 pmol/l on (b)(6) 2025, sid (b)(6), initial ft4 result (b)(6) = 33.2 pmol/l; repeat result= 12.1 pmol/l on (b)(6) 2025, sid (b)(6), initial ft4 result (b)(6) = 27.8 pmol/l; repeat result= 18.8 pmol/l on (b)(6) 2025, sid (b)(6), initial ft4 result (b)(6) = 35.8 pmol/l; repeat result= 15.4 pmol/l on(b)(6) 2025, sid (b)(6), initial ft4 result (b)(6) = 29.9 pmol/l; repeat result= 16 pmol/l on (b)(6) 2025, sid (b)(6), initial ft4 result (b)(6) = 25 pmol/l; repeat result= 18.6 pmol/l on (b)(6) 2025, sid (b)(6), initial ft4 result (b)(6) = 24.9 pmol/l; repeat result= 17.9 pmol/l on(b)(6) 2025, sid (b)(6), initial ft4 result (b)(6) = 65 pmol/l; repeat result= 17.3 pmol/l on (b)(6) 2025, sid (b)(6) initial ft4 result (b)(6) = 29.2 pmol/l; repeat result= 17 pmol/l there was no impact to patient management reported.
Additional Manufacturer Narrative
Section a1 - patient identifier: sample ids = (b)(6) an evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed erratic alinity i free t4 for multiple patients.The following results were provided (reference range 9 - 19 pmol/l): (b)(6) 2025, sid (b)(6), initial ft4 result (b)(6)= 7.8 pmol/l; repeat result= 11.7 pmol/l, (b)(6) 2025, sid (b)(6), initial ft4 result (b)(6)= 33.2 pmol/l; repeat result= 12.1 pmol/l, (b)(6) 2025, sid (b)(6), initial ft4 result (b)(6)= 27.8 pmol/l; repeat result= 18.8 pmol/l, (b)(6) 2025, sid(b)(6) , initial ft4 result (b)(6)= 35.8 pmol/l; repeat result= 15.4 pmol/l, (b)(6) 2025, sid(b)(6) , initial ft4 result (b)(6)= 29.9 pmol/l; repeat result= 16 pmol/l, (b)(6) 2025, sid(b)(6) , initial ft4 result (b)(6)= 25 pmol/l; repeat result= 18.6 pmol/l, (b)(6) 2025, sid(b)(6) , initial ft4 result (b)(6)= 24.9 pmol/l; repeat result= 17.9 pmol/l, (b)(6) 2025, sid (b)(6), initial ft4 result (b)(6)= 65 pmol/l; repeat result= 17.3 pmol/l.(b)(6) 2025, sid (b)(6), initial ft4 result (b)(6)= 29.2 pmol/l; repeat result= 17 pmol/l there was no impact to patient management reported.
Additional Manufacturer Narrative
A complaint investigation was conducted for the alinity i free t4 reagent with unknown lot.Data and information provided by the customer were reviewed and support the complaint issue.Review of tracking and trending did not identify any trends.Device history review did not identify issues associated with the customer¿s observation.Labeling was reviewed which adequately addresses the current issue.Based on our investigation, no systemic issue or deficiency was identified with the alinity i free t4 reagent.

• 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: 23200099
• Report Number: 3005094123-2025-00497
• Device Sequence Number: 21190674
• Product Code: CEC
• UDI-Device Identifier: 00380740121815
• UDI-Public: (01)00380740121815
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 12/16/2025

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 Catalogue Number: 07P70-20
• 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: 09/18/2025
• Supplement Date Received by Manufacturer: 12/11/2025
• Initial Report FDA Received Date: 10/02/2025
• Supplement Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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),; ALNTY I PROCESSING MODU,03R65-01,(B)(6),; ALNTY I PROCESSING MODU,03R65-01,(B)(6),; ALNTY I PROCESSING MODU,03R65-01,(B)(6),; ALNTY I PROCESSING MODU,03R65-01,(B)(6),; 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 Sex: Unknown