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

Catalog Number	07K62-25
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2025
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.
Event or Problem Description
The customer reported falsely elevated architect tsh result generated by the architect i1000sr processing module for a patient.The sample was repeated, and a normal result was obtained.The following data was provided: customer's reference range: 0.35 iu/ml to 4.94 iu/ml.Sid (b)(6): initial tsh result = 9.0642 iu/ml; repeat result = 4.189 iu/ml no impact to patient management was reported.
Event or Problem Description
The customer reported falsely elevated architect tsh result generated by the architect i1000sr processing module for a patient.The sample was repeated, and a normal result was obtained.The following data was provided: customer's reference range: 0.35 iu/ml to 4.94 iu/ml.Sid (b)(6): initial tsh result = 9.0642 iu/ml; repeat result = 4.189 iu/ml no impact to patient management was reported.
Additional Manufacturer Narrative
All available patient information was included.Additional patient details are not available.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 were reviewed and support the complaint issue.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 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.The overall performance of architect tsh reagents in the field was reviewed using data gathered from customers worldwide.The patient¿s data was analyzed and compared to an established control limit.This evaluation indicated that the patient median result for lot 73446ud00 is within the established control limits.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.

• 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: 22769452
• Report Number: 3005094123-2025-00390
• Device Sequence Number: 18477175
• Product Code: JLW
• UDI-Device Identifier: 00380740014230
• UDI-Public: (01)00380740014230(17)260819(10)73446UD00
• 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): 09/08/2025

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: 08/19/2026
• 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: 07/26/2025
• Supplement Date Received by Manufacturer: 08/28/2025
• Initial Report FDA Received Date: 08/11/2025
• Supplement Report FDA Received Date: 09/08/2025
• 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 I1000SR MOD, 01L86-01, (B)(6).; ARC I1000SR MOD, 01L86-01, (B)(6).
• Patient Sex: Unknown