MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ARCHITECT TSH; RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE

Catalog Number	07K62-25
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2025
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.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer reported a discrepant architect tsh result on a patient.The following results were provided: (b)(6) 2025, sid (b)(6), serum = 2.9497 / 2.8832 / 3.2478 uiu/ml, plasma = 8.3296 uiu/ml; previous result from (b)(6) 2025 = 10.61 uiu/ml.Reference range: 0.3-4.2 uiu/ml.The patient had their thyroid medication temporarily delayed due to the low falsely low tsh result.No further impact to patient management was reported.
Additional Manufacturer Narrative
The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, device history record review, retained product analysis, and labeling review.Data and information provided by the customer were reviewed and support the complaint issue.Review of tracking and trending for the architect tsh assay did not identify any trends.Additionally, an increase in complaint activity was not identified for reagent lot 73446ud00.A device history record review was performed on lot 73446ud00 which did not show any non-conformances, deviations, or potential non-conformances related to the issue under review.Retained product testing met all acceptance criteria indicating the product is performing as expected.Labeling was reviewed and found to adequately address the issue under review.Based on the investigation, no systemic issue or deficiency of the architect tsh reagent lot 73446ud00 was identified.
Event or Problem Description
The customer reported a discrepant architect tsh result on a patient.The following results were provided: (b)(6) 2025 sid (b)(6) serum = 2.9497 / 2.8832 / 3.2478 uiu/ml, plasma = 8.3296 uiu/ml; previous result from (b)(6) 2025 = 10.61 uiu/ml reference range: 0.3-4.2 uiu/ml.The patient had their thyroid medication temporarily delayed due to the low falsely low tsh result.No further impact to patient management was reported.

• Brand Name: ARCHITECT TSH
• 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: 23497566
• Report Number: 3005094123-2025-00565
• Device Sequence Number: 9115910
• Product Code: JLW
• UDI-Device Identifier: 00380740014230
• UDI-Public: (01)00380740014230(17)260819(10)73446UD00
• 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): 01/23/2026

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: 08/19/2026
• Device Catalogue Number: 07K62-25
• Device Lot Number: 73446UD00
• 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: 10/23/2025
• Supplement Date Received by Manufacturer: 01/09/2026
• Initial Report FDA Received Date: 11/07/2025
• Supplement Report FDA Received Date: 01/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2025
• 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: ARC I2000SR INST, 03M74-02, ISR60603.; ARC I2000SR INST, 03M74-02, ISR60603.
• Patient Sex: Unknown