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

Catalog Number	07K62-25
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2025
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 falsely depressed architect tsh results for one patient.The following results were provided: architect tsh result 1.7 and 1.76 iu/ ml, repeated 1.74 iu/ ml and 1.7957 uiu/ml and 1.7417 uiu/ml.The customer retested the sample on different abbott equipment as well, and the value obtain was 1.7563 uiu/ml.Same sample tested on beckman coulter analyzer result reported 7.53 iu/ ml and roche reported 8.990 iu/ ml.No impact to patient management was reported.
Additional Manufacturer Narrative
The complaint investigation 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 performance evaluation of a retained kit of reagent lot 69302ud00.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.Review of tracking and trending for the architect tsh reagent kit lot 69302ud00 did not identify an increase in complaint activity related to the complaint issue.A review of the device history record did not identify any nonconformances or deviations with the complaint lot.Accuracy testing was performed to evaluate the performance of reagent lot 69302ud00.An internal panel was tested with retained kits of the reagent lot.Acceptance criteria were met, indicating acceptable product performance.Labeling was reviewed and adequately addresses the issue under review.Based on the investigation, no systemic issue or product deficiency of the architect tsh reagent kit lot 69302ud00 was identified.
Event or Problem Description
The customer observed falsely depressed architect tsh results for one patient.The following results were provided: architect tsh result 1.7 and 1.76 iu/ ml, repeated 1.74 iu/ ml and 1.7957 uiu/ml and 1.7417 uiu/ml.The customer retested the sample on different abbott equipment as well, and the value obtain was 1.7563 uiu/ml.Same sample tested on beckman coulter analyzer result reported 7.53 iu/ ml and roche reported 8.990 iu/ ml.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: 21876198
• Report Number: 3005094123-2025-00182
• Device Sequence Number: 18117655
• Product Code: JLW
• UDI-Device Identifier: 00380740014230
• UDI-Public: (01)00380740014230(17)260411(10)69302UD00
• 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): 07/08/2025

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: 04/11/2026
• Device Catalogue Number: 07K62-25
• Device Lot Number: 69302UD00
• 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: 04/01/2025
• Supplement Date Received by Manufacturer: 06/25/2025
• Initial Report FDA Received Date: 04/21/2025
• Supplement Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2024
• 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 I1SR REFURB-SEKAT, 01L86-97, (B)(6),; ARC I1SR REFURB-SEKAT, 01L86-97, (B)(6).
• Patient Sex: Unknown