MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ARCHITECT TSH REAGENT KIT; 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	12/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complete information for section a patient information, 1.Patient identifier = sid= (b)(6).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 observed falsely elevated architect tsh results on one patient.The results provided were: on (b)(6) 2024 sid (b)(6) initial tsh=3.44 uiu/ml /repeated=2.78 and 4.58 uiu/ml.There was no reported impact to patient management.
Event or Problem Description
The customer observed falsely elevated architect tsh results on one patient.The results provided were: on (b)(6) 2024 sid (b)(6) initial tsh=3.44 uiu/ml /repeated=2.78 and 4.58 uiu/ml.Ft4 initial=3.07 ng/dl /repeated=1.19 ng/dl and 1.04 ng/dl there was no reported impact to patient management.
Additional Manufacturer Narrative
The complaint evaluation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review and field data of architect tsh reagent lot number 61613ud00.The ticket search by lots indicates that the reagent lot performs as expected for the issue under review.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 61613ud00.Return testing was not completed as returns were not available.Device history record review did not identify any non-conformances or deviations with the complaint lot and complaint issue.Historical performance of the architect tsh reagents in the field was reviewed using data gathered via abbottlink from customers worldwide.The median population result for the complaint lot 61613ud00 is within established limits, indicating that the lot is performing acceptably in the field.A manufacturing documentation for the likely cause lot did not identify any issues associated with the complaint issue.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation no product deficiency was identified for the architect tsh, reagent lot 61613ud00.

• 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: 20990332
• Report Number: 3005094123-2024-00660
• Device Sequence Number: 7958329
• Product Code: JLW
• UDI-Device Identifier: 00380740014230
• UDI-Public: (01)00380740014230(17)250808(10)61613UD00
• 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): 02/26/2025

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: 08/08/2025
• Device Catalogue Number: 07K62-25
• Device Lot Number: 61613UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/02/2024
• Supplement Date Received by Manufacturer: 02/25/2025
• Initial Report FDA Received Date: 12/20/2024
• Supplement Report FDA Received Date: 02/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2024
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARC I2K PROC MOD, 03M74-01, (B)(6); ARC I2K PROC MOD, 03M74-01, (B)(6)
• Patient Sex: Unknown