MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ALINITY I TSH REAGENT KIT; RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE

Catalog Number	07P48-30
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported false elevated alinity i tsh for one female patient born in 1995.A new sample from the same patient had lower results.The following data was provided: sid (b)(6) processed on (b)(6) 2025 reagent lot 79194ud00: alinity i serial number (b)(6) result = 276.491 and >100.000 alinity i serial number (b)(6) result = 271.368.Sid (b)(6) processed on (b)(6) 2026 reagent lot 80653ud00 on alinity i serial number (b)(6) = 2.483.Customer¿s tsh reference range = 0.4-4.0 me/l.No impact to patient management was reported.
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 reported false elevated alinity i tsh for one female patient born in 1995.A new sample from the same patient had lower results.The following data was provided: sid (b)(6) processed on (b)(6) 2025 reagent lot 79194ud00: alinity i serial number (b)(6) result = 276.491 and >100.000, alinity i serial number (b)(6) result = 271.368.Sid (b)(6) processed on (b)(6) 2026 reagent lot 80653ud00 on alinity i serial number (b)(6) = 2.483.Customer¿s tsh reference range = 0.4-4.0 me/l no impact to patient management was reported.
Additional Manufacturer Narrative
Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.A review of tracking and trending for the alinity i tsh assay did not identify any trends related to the complaint issue.Additionally, no trends were identified for lot 79194ud00.Device history record review did not identify any non-conformances, potential non-conformances or deviations with the complaint lot and issue.The overall performance of alinity i tsh reagents in the field was reviewed using data gathered from customers worldwide.The median population values for the complaint lot are within the established limits indicating that the lot is performing acceptably.Labeling was reviewed and sufficiently addresses the customer¿s issue.Based on the investigation, no system issue or deficiency of the alinity i tsh reagent lot 79194ud00 was identified.

• Brand Name: ALINITY I TSH REAGENT KIT
• Common Device Name: RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE
• 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: 24209404
• Report Number: 3005094123-2026-00048
• Device Sequence Number: 5431272
• Product Code: JLW
• UDI-Device Identifier: 00380740131159
• UDI-Public: (01)00380740131159(17)270205(10)79194UD00
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K983442
• 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): 03/11/2026

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: 07P48-30
• Device Lot Number: 79194UD00
• 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: 01/20/2026
• Supplement Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 01/29/2026
• Supplement Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2025
• 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).; ALNTY I PROCESSING MODU, 03R65-01, (B)(6).
• Patient Sex: Female