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	05/08/2025
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.
Event or Problem Description
The customer reported falsely elevated alinity i tsh and provided the following data: the patient has had elevated tsh results.On (b)(6), the patient was tested for tsh while in (b)(6) and generated a result of 1.714 miu/l (platform unknown).On (b)(6) 2025, the facility that the patient is normally tested at generated a result of 5.85 miu/l.On (b)(6) 2025, the patient went to another facility and the tsh result on the centaur platform was 2.54 miu/l on (b)(6) 2025, a new sample was tested on alinity platform, which generated a result of 4.61 miu/l and architect platform generated a result of 4.7 miu/l.Package insert normal range is 0.35 iu/ml to 4.94 miu/l.Historical tsh results: on (b)(6) 2025 with analyzer (b)(6) the result was 5.85.On (b)(6) 2025 with analyzer (b)(6) the result was 7.37.On (b)(6) 2025 with analyzer (b)(6) the result was 5.64.On (b)(6) 2025 with analyzer (b)(6) the result was 4.8.On (b)(6) 2025 with analyzer (b)(6) the result was 5.12.On (b)(6) 2025 with analyzer (b)(6) the result was 5.74.On (b)(6) 2024 with analyzer (b)(6) the result was 4.17.Patient information: female patient waiting to start ivf.Her physician has not started due to elevated tsh results.There was no reported impact to patient management.
Additional Manufacturer Narrative
The complaint investigation included a review of data and information provided by the customer, search for similar complaints, trending review, labeling review, device history record review, and field data review.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.Device history review for the complaint lot did not identify any issues.A review of tracking and trending for the alinity i tsh result reagent and complaint lot did not identify an increase in complaints for the complaint issue.The overall performance of the alinity i tsh result reagent reviewed using field data from customers.The review of field data for the complaint lot determined the median values are within the established limits and concluded complaint lot is performing as expected.Labeling was reviewed and was found to address the customer reported event.Based on the available information, no systemic issue or deficiency was identified for the alinity i tsh result reagent lot: 68304ud00.
Event or Problem Description
The customer reported falsely elevated alinity i tsh and provided the following data: the patient has had elevated tsh results.On (b)(6), the patient was tested for tsh while in (b)(6) and generated a result of 1.714 miu/l (platform unknown).On (b)(6) 2025, the facility that the patient is normally tested at generated a result of 5.85 miu/l.On (b)(6) 2025, the patient went to another facility and the tsh result on the centaur platform was 2.54 miu/l on (b)(6) 2025, a new sample was tested on alinity platform, which generated a result of 4.61 miu/l and architect platform generated a result of 4.7 miu/l.Package insert normal range is 0.35 iu/ml to 4.94 miu/l.Historical tsh results: on (b)(6) 2025 with analyzer (b)(6) the result was 5.85, on (b)(6) 2025 with analyzer (b)(6) the result was 7.37, on (b)(6) 2025 with analyzer (b)(6) the result was 5.64, on (b)(6) 2025 with analyzer (b)(6) the result was 4.8, on (b)(6) 2025 with analyzer (b)(6) the result was 5.12, on (b)(6) 2025 with analyzer (b)(6) the result was 5.74, on (b)(6) 2024 with analyzer (b)(6) the result was 4.17.Patient information: female patient waiting to start ivf.Her physician has not started due to elevated tsh results.There was no reported impact to patient management.

• 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: 22114237
• Report Number: 3005094123-2025-00266
• Device Sequence Number: 14515881
• Product Code: JLW
• UDI-Device Identifier: 00380740131159
• UDI-Public: (01)00380740131159(17)260318(10)68304UD00
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• 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): 07/29/2025

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: 03/18/2026
• Device Catalogue Number: 07P48-30
• Device Lot Number: 68304UD00
• 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: 05/18/2025
• Supplement Date Received by Manufacturer: 07/14/2025
• Initial Report FDA Received Date: 05/30/2025
• Supplement Report FDA Received Date: 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2024
• 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).
• Patient Sex: Unknown