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	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2025
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.
Event or Problem Description
The customer observed falsely decreased alinity i free t4 results for 34-year-old patient female patient diagnosed with thyrotoxicosis and is currently undergoing treatment.The following results were provided: (normal range: 9.01 - 19.05 pmol/l) on (b)(6) 2025, sid (b)(6), initial free t4 result = 18.58 pmol/l, repeat result = 18.68 pmol/l, result on roche cobas = 28.92 pmol/l (normal range: 12-22 pmol/l) historical results on a different analyzer free t4 result = 50.7 pmol/l results from (b)(6) 2025 on alinity free t4 result = 42.77 pmol/l addtiional lab results: tsh = < 0.0083 uiu/ml, free t3 = 9.170 pmol/l, trab = 6.590 iu/l historical results on a different analyzer: tsh = 0.005 uiu/ml free t3 = 23.6 pmol/l trab = 8.68 iu/l anti-tpo = 20.3 iu/ml results from (b)(6) 2025 on alinity with reference ranges: tsh = <0.0083 uiu/ml (0.350 - 4.940 uiu/ml) free t3 = >30.72 pmol/l (2.427-6.006 pmol/l) trab = 6.77 iu/l (<3.100 iu/l) anti-tpo = 13.9 iu/ml (< 5.61 iu/ml) the customer mentioned they are only questioning the free t4 results as being incorrect.No impact to patient management was reported.
Additional Manufacturer Narrative
The complaint investigation for false depressed alinity i free t4 results included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review, and in house testing.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.Review of tracking and trending for the alinity i free t4 assay did not identify an increase in complaint activity related to the complaint issue.Additionally, an increase in complaint activity was not identified for reagent lot 73276ud00.The device history record review did not identify any nonconformances, potential nonconformances, or deviations associated with the list number.In house accuracy testing of the retained analysis of alinity i free t4 reagent lot 73276ud00 was performed.Testing met acceptance criteria and the product is performing as expected.Labeling was reviewed and sufficiently addresses the customer's issue.Based on the investigation, no systemic issue or deficiency with the alinity i free t4 assay for lot 73276ud00 was identified.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer observed falsely decreased alinity i free t4 results for 34-year-old patient female patient diagnosed with thyrotoxicosis and is currently undergoing treatment.The following results were provided: (normal range: 9.01 - 19.05 pmol/l) (b)(6) 2025 sid (b)(6), initial free t4 result = 18.58 pmol/l, repeat result = 18.68 pmol/l, result on roche cobas = 28.92 pmol/l (normal range: 12-22 pmol/l).Historical results on a different analyzer free t4 result = 50.7 pmol/l.Results from (b)(6) 2025 on alinity free t4 result = 42.77 pmol/l.Addtiional lab results: tsh = < 0.0083 uiu/ml, free t3 = 9.170 pmol/l, trab = 6.590 iu/l historical results on a different analyzer: tsh = 0.005 uiu/ml, free t3 = 23.6 pmol/l, trab = 8.68 iu/l, anti-tpo = 20.3 iu/ml.Results from (b)(6) 2025 on alinity with reference ranges: tsh = <0.0083 uiu/ml (0.350 - 4.940 uiu/ml), free t3 = >30.72 pmol/l (2.427-6.006 pmol/l), trab = 6.77 iu/l (<3.100 iu/l), anti-tpo = 13.9 iu/ml (< 5.61 iu/ml).The customer mentioned they are only questioning the free t4 results as being incorrect.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: 23232497
• Report Number: 3005094123-2025-00503
• Device Sequence Number: 8588216
• Product Code: CEC
• UDI-Device Identifier: 00380740121815
• UDI-Public: (01)00380740121815(17)260205(10)73276UD00
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• 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 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: 09/24/2025
• Supplement Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 10/07/2025
• Supplement Report FDA Received Date: 12/16/2025
• 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)
• Patient Age: 34 YR
• Patient Sex: Female