MAUDE Adverse Event Report: Abbott Ireland Diagnostics Division Alinity I Free T4 Reagent Kit; Radioimmunoassay, free thyroxine

Catalog Number	07P70-30
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported falsely elevated alinity i free t4 generated from alinity i processing module (sn:(b)(6)) and provided the following data for a 74 year old female patient: on (b)(6)2026, sample id (b)(6) initial result was 24.4 pmol/l and when repeated on another alinity i processing module, the result was 13.7 pmol/ l (customer normal range: 9-19.9 pmol/l).Other laboratory data provided: tsh was 2.29 miu/l (reference range: 0.35-4.94) per the customer discrepant results were not reported out to the medical provider.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.Section e1 - region state complete entry =(b)(6).Section a patient information: refer to section b5 for complete patient information.All available patient information was included.Additional patient details are not available.

• 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 ; +49()6122582960
• MDR Report Key: 50916380
• Report Number: 3005094123-2026-00486
• Device Sequence Number: 20278238
• Product Code: CEC
• UDI-Device Identifier: 00380740121822
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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
• Report Date (Section B): 09/28/2026

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 Catalogue Number: 07P70-30
• Device Lot Number: 86129UD00
• 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: 09/08/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/16/2026
• 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).
• Patient Age: 74 YR
• Patient Sex: Female