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	02/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported a falsely depressed architect tsh results for a 17-year-old male patient.The following information was provided: architect results (b)(6) 2025, sid (b)(6): tsh: 0.09 uiu/ml, customer provided normal value: 0.35 to 4.94 uiu/ml, (0.09 miu/l, normal value: 0.35 to 4.94 miu/l).Beckman results at another laboratory: tsh: 1.49 miu/l (customer provided normal value: 0.38 to 5.33 miu/l).The physician questioned the result generated on the architect as they did not match clinical presentation including no known pathology, no tsh anti-receptor antibodies, and a normal thyroid ultrasound.No impact to patient management was reported.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
Return testing was not completed as returns were not available.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 67213ud00.A device history record review did not identify any non-conformances, deviations, or potential non-conformances related to lot number 67213ud00 and complaint issue.In-house accuracy testing was performed with a retained kit of reagent lot 67213ud00.Testing met acceptance criteria, and the product is performing as expected.Labeling was reviewed which adequately addresses the current issue.Based on the available information, no systemic issue or deficiency of the architect tsh reagent lot number 67213ud00 was identified.
Event or Problem Description
The customer reported a falsely depressed architect tsh results for a 17 year old male patient.The following information was provided: architect results ((b)(6) 2025, sid (b)(6)): tsh: 0.09 uiu/ml, customer provided normal value: 0.35 to 4.94 uiu/ml, (0.09 miu/l, normal value: 0.35 to 4.94 miu/l).Beckman results at another laboratory: tsh: 1.49 miu/l (customer provided normal value: 0.38 to 5.33 miu/l).The physician questioned the result generated on the architect as they did not match clinical presentation including no known pathology, no tsh anti-receptor antibodies, and a normal thyroid ultrasound.No impact to patient management was reported.
Additional Manufacturer Narrative
Completed information for section a1 patient identifier: sid (b)(6).Section d3 email was updated from (b)(4).Section g1 mfg site email was updated from (b)(4).
Event or Problem Description
The customer reported a falsely depressed architect tsh results for a 17-year-old male patient.The following information was provided: architect results (b)(6) 2025, sid (b)(6): tsh: 0.09 uiu/ml, customer provided normal value: 0.35 to 4.94 uiu/ml, (0.09 miu/l, normal value: 0.35 to 4.94 miu/l) beckman results at another laboratory: tsh: 1.49 miu/l (customer provided normal value: 0.38 to 5.33 miu/l) the physician questioned the result generated on the architect as they did not match clinical presentation including no known pathology, no tsh anti-receptor antibodies, and a normal thyroid ultrasound.No impact to patient management was 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: 21786205
• Report Number: 3005094123-2025-00145
• Device Sequence Number: 8647800
• Product Code: JLW
• UDI-Device Identifier: 00380740014247
• UDI-Public: (01)00380740014247(17)260227(10)67213UD00
• 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,Followup
• Report Date (Section B): 06/25/2025

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: 02/27/2026
• Device Catalogue Number: 07K62-30
• Device Lot Number: 67213UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/17/2025
• Supplement Date Received by Manufacturer: 06/24/2025; 06/24/2025
• Initial Report FDA Received Date: 04/07/2025
• Supplement Report FDA Received Date: 06/25/2025; 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2024
• 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 I2SR REFURB-SEKAT, 03M74-97, (B)(6) ; ARC I2SR REFURB-SEKAT, 03M74-97, (B)(6) ; ARC I2SR REFURB-SEKAT, 03M74-97, (B)(6)
• Patient Age: 17 YR
• Patient Sex: Male