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

Catalog Number	07P48-20
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2026
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.Section a patient information: refer to section b5 for complete patient information.
Event or Problem Description
The customer reported falsely decreased alinity i tsh generated from alinity i processing module and provided the following data: on (b)(6) 2026 sample id 105105 tsh result was 0.2512 and when repeated the result was 0.2653 (alinity reference range 0.35-4.94 miu/ml) tsh result on the roche analyzer at another hospital was 0.469 miu/ml.(normal range for tsh assay on the roche analyzer: 0.27-4.2 miu/ml) when the sample was retested on the snibe platform, the resutls were 0.304 miu/ml & 0.28 miu/ml.(snibe reference range: 0.3 - 4.5 miu/ml) patient information: male; 46 years old.Diagnostics: a hypertensive crisis; the patient is not taking any medication.Additional laboratory data provided: ft4 12.97 pmol/l; tni mi rs 2.0 ng/l 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: 24796180
• Report Number: 3005094123-2026-00165
• Device Sequence Number: 10682454
• Product Code: JLW
• UDI-Device Identifier: 00380740131142
• UDI-Public: (01)00380740131142(17)260617(10)71591UD00
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• 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): 05/08/2026

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 Expiration Date: 06/17/2026
• Device Catalogue Number: 07P48-20
• Device Lot Number: 71591UD00
• 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: 03/19/2026
• Supplement Date Received by Manufacturer: 05/08/2026
• Initial Report FDA Received Date: 04/06/2026
• Supplement Report FDA Received Date: 05/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2025
• 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)
• Patient Age: 46 YR
• Patient Sex: Male