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	06/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed a falsely depressed architect tsh result for one patient diagnosed with autoimmune thyroiditis.The following data was provided: (b)(6) 2023 initial result = 17.06 miu/l (testing completed at another laboratory).(b)(6) 2023 sid (b)(6) initial result = 6.98 miu/l.(b)(6) 2023 initial result = 17.7 miu/l (testing completed at another laboratory).(b)(6) 2023 initial result = 14.05 miu/l 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.
Event or Problem Description
The customer observed a falsely depressed architect tsh result for one patient diagnosed with autoimmune thyroiditis.The following data was provided: on (b)(6) 2023, initial result = 17.06 miu/l (testing completed at another laboratory) on (b)(6) 2023 ,sid (b)(6) initial result = 6.98 miu/l on (b)(6) 2023, initial result = 17.7 miu/l (testing completed at another laboratory) on (b)(6) 2023, initial result = 14.05 miu/l no impact to patient management was reported.
Additional Manufacturer Narrative
The complaint investigation for falsely depressed architect tsh results included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, and device history record review.A search for similar complaints did not identify an increase in complaint activity.Trending review did not identify any trends for the issue for the product.Device history record review did not identify any related nonconformance's, potential nonconformance's, or deviations associated with the likely lot number 45584ud00 and complaint issue.Labeling was reviewed and sufficiently addresses the customer's issue.Based on our investigation, no systemic issue or deficiency with the architect tsh reagent for lot 45584ud00 was identified.
Additional Manufacturer Narrative
An evaluation is still in process.A follow-up report will be submitted when the evaluation is complete.After further review, section d4 catalog # was updated from 07k62-25 to 07k62-30.Section d4 unique identifier (udi) # was updated from (b)(4).H3 other text : device evaluation still in process.
Event or Problem Description
The customer observed a falsely depressed architect tsh result for one patient diagnosed with autoimmune thyroiditis.The following data was provided: 13jun2023 initial result = 17.06 miu/l (testing completed at another laboratory).19jun2023 sid (b)(6) initial result = 6.98 miu/l.29jun2023 initial result = 17.7 miu/l (testing completed at another laboratory).01jul2023 initial result = 14.05 miu/l 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: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 17388550
• Report Number: 3005094123-2023-00192
• Device Sequence Number: 5929423
• Product Code: JLW
• UDI-Device Identifier: 00380740014247
• UDI-Public: 00380740014247
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• 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): 09/27/2023

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: 04/04/2024
• Device Catalogue Number: 07K62-30
• Device Lot Number: 45584UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/07/2023
• Supplement Date Received by Manufacturer: 08/22/2023; 09/27/2023
• Initial Report FDA Received Date: 07/25/2023
• Supplement Report FDA Received Date: 09/11/2023; 09/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2022
• 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 I2000SR INST, 03M74-02, (B)(6); ARC I2000SR INST, 03M74-02, (B)(6); ARC I2000SR INST, 03M74-02, (B)(6)
• Patient Sex: Unknown