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

Catalog Number	07K62-30
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed falsely depressed architect tsh for one patient.The following results were provided (reference range 0.350-4.940 mui/l): (b)(6) 2025, sid (b)(6), initial tsh result= 0.0569 mui/l; (b)(6) 2025, historical result= 0.0483 mui/l; repeat result (roche)= 0.77 mui/l (reference range 0.27-4.20 mui/l); (b)(6) 2025, historical result (roche)= 0.88 mui/l; repeat result (siemens)= 0.70 mui/l (reference range 0.55-4.78 mui/l) there was no impact to patient management reported.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Complete information from section a1.Patient identifier sid (b)(6).
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, field data review and labeling review.Data and information provided by the customer confirms the complaint issue and no additional issues were identified.Review of tracking and trending for the architect tsh assay did not identify an increase in complaint activity related to the complaint issue.Additionally, an increase in complaint activity was not identified for reagent lot 73531ud00.A device history record review did not identify any related nonconformances, potential nonconformances or deviations associated with the complaint lot number and complaint issue.The overall performance of the architect tsh reagents 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.Labelling 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 73531ud00 was identified.
Event or Problem Description
The customer observed falsely depressed architect tsh for one patient.The following results were provided (reference range 0.350-4.940 mui/l): on (b)(6) 2025, sid (b)(6), initial tsh result= 0.0569 mui/l; (b)(6) 2025, historical result= 0.0483 mui/l; repeat result (roche)= 0.77 mui/l (reference range 0.27-4.20 mui/l); (b)(6) 2025, historical result (roche)= 0.88 mui/l; repeat result (siemens)= 0.70 mui/l (reference range 0.55-4.78 mui/l) there was no impact to patient management 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: 23051856
• Report Number: 3005094123-2025-00455
• Device Sequence Number: 9824950
• Product Code: JLW
• UDI-Device Identifier: 00380740014247
• UDI-Public: (01)00380740014247(17)260824(10)73531UD00
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 10/22/2025

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: 08/24/2026
• Device Catalogue Number: 07K62-30
• Device Lot Number: 73531UD00
• 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: 09/04/2025
• Supplement Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 09/15/2025
• Supplement Report FDA Received Date: 10/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/10/2025
• 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, (B)(6); ARC I2000SR INST, 03M74-02, (B)(6)
• Patient Sex: Unknown