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	03/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A1 - patient identifier : complete sample id: (b)(6) 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 reported falsely decreased architect tsh for a 72-year-old outpatient cardiology department due to atrial septal defect.The patient has a medical history of hashimoto¿s disease.The patient is consulting another medical institution for their thyroid disease.The tsh results were compared between other platforms.The following data was provided: on (b)(6) 2024, sid (b)(6): architect tsh = 4.062 / 4.068 uiu/ml (using lot 56169ud00) lumipulse tsh = 9 uiu/ml cobas outsourcing tsh = 10 uiu/ml other testing: architect bnp = 33.9 pg/ml architect ft4 = 0.92 ng/ dl lumipulse ft4 = 0.9 ng/ml cobas outsourcing ft4 = 0.9 ng/ml on (b)(6) 2024, sid (b)(6) (same specimen): architect tsh = 3.9827 uiu/ml (using lot 57370ud00) architect free t4 = 0.90 ng/dl there was no impact to patient management reported.
Event or Problem Description
The customer reported falsely decreased architect tsh for a 72-year-old outpatient cardiology department due to atrial septal defect.The patient has a medical history of hashimoto¿s disease.The patient is consulting another medical institution for their thyroid disease.The tsh results were compared between other platforms.The following data was provided: on (b)(6) 2024, sid (b)(6) : architect tsh = 4.062 / 4.068 uiu/ml (using lot 56169ud00).Lumipulse tsh = 9 uiu/ml.Cobas outsourcing tsh = 10 uiu/ml.Other testing: architect bnp = 33.9 pg/ml.Architect ft4 = 0.92 ng/ dl.Lumipulse ft4 = 0.9 ng/ml.Cobas outsourcing ft4 = 0.9 ng/ml.On (b)(6) 2024, sid (b)(6) (same specimen): architect tsh = 3.9827 uiu/ml (using lot 57370ud00).Architect free t4 = 0.90 ng/dl.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.A ticket search for lot 56169ud00 did not identify an increase in complaint activity related to the issue under review.A review of ticket tracking and trending and did not identify any related trends for the product for the issue.The historical performance of reagent lot 56169ud00 was evaluated using worldwide data from customers in the field for the 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 56169ud00 is within the established control limits.Therefore, no unusual reagent lot performance was identified for 56169ud00.The device history record was reviewed and did not identify any non-conformances or deviations associated with the complaint lot and the issue under review.Labeling was reviewed and adequately addresses the issue under review.Based on the investigation, no systemic issue or product deficiency was identified for architect tsh reagent lot 56169ud00.

• 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: 19333430
• Report Number: 3005094123-2024-00260
• Device Sequence Number: 16909958
• Product Code: JLW
• UDI-Device Identifier: 00380740014230
• UDI-Public: (01)00380740014230(17)250306(10)56169UD00
• 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: 03/06/2025
• Device Catalogue Number: 07K62-25
• Device Lot Number: 56169UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/01/2024
• Supplement Date Received by Manufacturer: 05/30/2024
• Initial Report FDA Received Date: 05/16/2024
• Supplement Report FDA Received Date: 06/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/29/2023
• 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 I1000SR MOD, 01L86-01, (B)(6) ; ARC I1000SR MOD, 01L86-01, (B)(6)
• Patient Age: 72 YR
• Patient Sex: Unknown