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	03/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed falsely depressed architect tsh results for one patient.The following data was provided: on (b)(6) 2024, initial tsh result = 11 uiu/ml; repeat result on (b)(6) 2024 = 10.182 uiu/ml.On (b)(6) 2024, tsh result from a new sample = 1.74 uiu/ml; repeat result on (b)(6) 2024 = 1.561 uiu/ml.There was no impact to patient management reported.
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 depressed architect tsh results for one patient.The following data was provided: on (b)(6) 2024, initial tsh result = 11 uiu/ml; repeat result on (b)(6) 2024 = 10.182 uiu/ml.On (b)(6) 2024, tsh result from a new sample = 1.74 uiu/ml; repeat result on (b)(6) 2024 = 1.561 uiu/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, search for similar complaints, ticket trending review, labeling review, device history record review, and field data review.Return testing was not completed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.The ticket search by lot indicates that the complaint lot performs as expected for this product.Ticket trending review did not identify any trends.Device history review did not identify any non-conformances or deviations with the complaint lot and issue under review.The historical performance of reagent lot 54659ud00 was evaluated using worldwide data for architect tsh assay.The patient¿s data was analyzed and compared to an established control limit.This evaluation indicated that the patient median result for lot 54659ud00 is within the established control limits.Therefore, no unusual reagent lot performance was identified for 54659ud00.Labeling was reviewed and adequately addresses the issue.Based on the investigation, no systemic issue or product deficiency was identified for architect tsh reagent lot 54659ud00.

• 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: 19038183
• Report Number: 3005094123-2024-00162
• Device Sequence Number: 6986164
• Product Code: JLW
• UDI-Device Identifier: 00380740014247
• UDI-Public: (01)00380740014247(17)250201(10)54659UD00
• 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): 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): 06/07/2024

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: 02/01/2025
• Device Catalogue Number: 07K62-30
• Device Lot Number: 54659UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/24/2024
• Supplement Date Received by Manufacturer: 05/28/2024
• Initial Report FDA Received Date: 04/03/2024
• Supplement Report FDA Received Date: 06/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2023
• 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 I2K PROC MOD, 03M74-01, (B)(6) ; ARC I2K PROC MOD, 03M74-01, (B)(6)
• Patient Sex: Unknown