MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ARCHITECT TSH REAGENT KIT; 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	02/22/2025
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 observed a falsely decreased architect tsh result generated by the architect i2000sr processing module for a patient, which was inconsistent with results from other platforms.The following data was provided: customer¿s reference range: 0.35 to 5.50 iu/ml.Sid (b)(6): (b)(6) 2025 architect tsh result = 5.460 iu/ml.Autobio platform result = 8.425 iu/ml.Outsourced result = 9.10 iu/ml.There was no impact to patient management reported.
Additional Manufacturer Narrative
The complaint investigation included a review of data and information provided by the customer, a ticket trending review, a device history record review, and a labeling review.Additionally, in-house testing of retained reagent kit was also completed.Return testing was not completed as returns were not available.The data and information provided by the customer were reviewed and supported the complaint issue.A 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 61060ud00.A review of the device history record did not identify any non-conformances or deviations with lot 61060ud00 and the complaint issue.A review of labeling was performed and found to sufficiently address the customer's issue.Accuracy testing was performed to evaluate the performance of reagent lot 61060ud00.An internal panel was tested with retained kits of reagent lot 61060ud00 and all specifications were met, which indicates acceptable product performance.Based on this investigation, no systemic issue or deficiency was identified with the architect tsh reagent, lot number 61060ud00.
Event or Problem Description
The customer observed a falsely decreased architect tsh result generated by the architect i2000sr processing module for a patient, which was inconsistent with results from other platforms.The following data was provided: customer¿s reference range: 0.35 to 5.50 iu/ml.Sid (b)(6): (b)(6) 2025 architect tsh result = 5.460 iu/ml, autobio platform result = 8.425 iu/ml, outsourced result = 9.10 iu/ml, there was no impact to patient management reported.

• Brand Name: ARCHITECT 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: 21604258
• Report Number: 3005094123-2025-00113
• Device Sequence Number: 21113970
• Product Code: JLW
• UDI-Device Identifier: 00380740014247
• UDI-Public: (01)00380740014247(17)250710(10)61060UD00
• 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): 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): 05/20/2025

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: 07/10/2025
• Device Catalogue Number: 07K62-30
• Device Lot Number: 61060UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/23/2025
• Supplement Date Received by Manufacturer: 05/16/2025
• Initial Report FDA Received Date: 03/14/2025
• Supplement Report FDA Received Date: 05/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2024
• 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