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	12/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed a falsely depressed architect tsh result for one female patient in her eighties who is not on any thyroid treatment when compared to another method.The following data was provided: patient architect results from (b)(6) 2025: tsh 3.16 uiu/ml other results = ft3 2.75 pg/ml ft4 2.10 ng/dl.Patient results from another method(cleia): tsh 7.10 uiu/ml other results = ft3 2.60 pg/ml ft4 0.97 ng/dl.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.See related report # 3005094123-2026-00038-00.
Event or Problem Description
The customer observed a falsely depressed architect tsh result for one female patient in her eighties who is not on any thyroid treatment when compared to another method.The following data was provided: patient architect results from (b)(6) 2025: tsh 3.16 uiu/ml other results = ft3 2.75 pg/ml ft4 2.10 ng/dl.Patient results from another method(cleia): tsh 7.10 uiu/ml other results = ft3 2.60 pg/ml ft4 0.97 ng/dl 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 architect tsh reagent did not identify any trends related to the complaint issue.Additionally, no trends were identified for lot 77205ud00.Device history record review did not identify any non-conformances, potential non-conformances or deviations associated with the complaint lot numbers.The overall performance of the architect tsh reagent in the field was reviewed using data gathered from customers worldwide.The median population result for the complaint lot is within established limits, indicating that the lot is performing acceptably in the field.Labeling was reviewed and sufficiently addresses the customer¿s issue.Based on the investigation, no systemic issue or deficiency of the architect tsh reagent lot 77205ud00 was identified.

• 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: 24180089
• Report Number: 3005094123-2026-00039
• Device Sequence Number: 21327004
• Product Code: JLW
• UDI-Device Identifier: 00380740014230
• UDI-Public: (01)00380740014230(17)261211(10)77205UD00
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K983442
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2026

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: 07K62-25
• Device Lot Number: 77205UD00
• 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: 01/08/2026
• Supplement Date Received by Manufacturer: 04/03/2026
• Initial Report FDA Received Date: 01/26/2026
• Supplement Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/23/2025
• 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: ARC I1000SR MOD, 01L86-01, (B)(6); ARC I1000SR MOD, 01L86-01, (B)(6)
• Patient Age: 80 YR
• Patient Sex: Female