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	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being filed on an international product, list number 07p48-30 that has a similar product distributed in the us, list number 07p48, with 510k number k983442.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed falsely depressed alinity i tsh results for a 32-year-old female patient.The following data was provided: sid (b)(6).Alinity i tsh result (b)(6) 2025 initial result 4.236 miu/l, repeated 4.05 miu/l.Roche result on (b)(6) 2025 was 96.20 uiu/ml.Iqraa hospital roche result (b)(6) 2025 = >100.0 uiu/ml beckman coulter result was 101.63 uiu/ml.A new sample was obtained, and the alinity i tsh results were 3.0570 and 3.0415 miu/l.Other results provided: total t3: 0.69 total t4: 2.93 no impact to patient management was reported.
Additional Manufacturer Narrative
A complaint investigation was conducted for the alinity i tsh reagent lot 74235ud00.Review of tracking and trending by list number and by complaint lot did not identify any trends.Device history review did not identify issues associated with the customer¿s observation.The overall performance of alinity i tsh reagents in the field was reviewed.The median population result for the complaint lot is within established limits, indicating that the lot is performing acceptably.The product labelling provides appropriate information related to the customer issue, which assists them in resolving their issue.Based on our investigation, no systemic issue or deficiency was identified with the alinity i tsh reagent lot 74235ud00.
Event or Problem Description
The customer observed falsely depressed alinity i tsh results for a 32-year-old female patient.The following data was provided: sid (b)(6).Alinity i tsh result (b)(6) 2025 initial result 4.236 miu/l, repeated 4.05 miu/l.Roche result on (b)(6) 2025 was 96.20 uiu/ml.(b)(6) hospital roche result 16oct2025 = >100.0 uiu/ml.Beckman coulter result was 101.63 uiu/ml.A new sample was obtained, and the alinity i tsh results were 3.0570 and 3.0415 miu/l.Other results provided: total t3: 0.69 total t4: 2.93 no impact to patient management was reported.

• 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: 23477881
• Report Number: 3005094123-2025-00557
• Device Sequence Number: 10227763
• Product Code: JLW
• UDI-Device Identifier: 00380740131159
• UDI-Public: (01)00380740131159(17)260907(10)74235UD00
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 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: 09/07/2026
• Device Catalogue Number: 07P48-30
• Device Lot Number: 74235UD00
• 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: 10/17/2025
• Supplement Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 11/05/2025
• Supplement Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2025
• 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: 32 YR
• Patient Sex: Female