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

Catalog Number	07K62-35
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2025
Type of Reportable Event	Malfunction
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 66118ud00.Review of all the information provided by the customer was reviewed.Data review of 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 66118ud00.Return testing was not performed as returns were not available.Historical performance of the architect tsh reagent in the field was reviewed using data gathered via abbottlink 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 66118ud00 is within the established control limits.Device history record review did not show any nonconformances, potential nonconformances or deviations associated with the likely cause list number and complaint issue.A review of labeling concluded that the issue is sufficiently addressed.Based on the investigation no product deficiency was identified for the architect tsh reagent lot 66118ud00.
Event or Problem Description
The customer observed falsely elevated alinity i tsh results on one 72yrs old female patient diagnosed with chronic cardiac failure and ovarian cancer.The results provided were: on (b)(6) 2025 initial=18.454 uiu/ml /recentrifuged and repeated=43.718 uiu/ml and 36.559 uiu/ml; repeated from plasma specimen=49.303 uiu/ml; repeated stored serum specimen on (b)(6) 2025=22.438 uiu/ml.Previous history on (b)(6) 2024=1.234 uiu/ml; on (b)(6) 2024=0.012 uiu/ml there was no reported impact to patient management.
Additional Manufacturer Narrative
All available patient information was included.Additional patient details are not available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed falsely elevated alinity i tsh results on one 72-year-old female patient diagnosed with chronic cardiac failure and ovarian cancer.The results provided were: on (b)(6) 2025 initial=18.454 uiu/ml /recentrifuged and repeated=43.718 uiu/ml and 36.559 uiu/ml; repeated from plasma specimen=49.303 uiu/ml; repeated stored serum specimen on (b)(6) 2025=22.438 uiu/ml.Previous history on (b)(6) 2024=1.234 uiu/ml; on (b)(6) 2024=0.012 uiu/ml there was no reported impact to patient management.

• 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: 21594373
• Report Number: 3005094123-2025-00109
• Device Sequence Number: 18374072
• Product Code: JLW
• UDI-Device Identifier: 00380740105969
• UDI-Public: (01)00380740105969(17)260111(10)66118UD00
• 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): 03/31/2025

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: 01/11/2026
• Device Catalogue Number: 07K62-35
• Device Lot Number: 66118UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/20/2025
• Supplement Date Received by Manufacturer: 03/31/2025
• Initial Report FDA Received Date: 03/13/2025
• Supplement Report FDA Received Date: 03/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2024
• 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 Age: 72 YR
• Patient Sex: Female