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	04/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 phone number is (b)(6).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 and provided the following data for a 10 year old (sample id (b)(6)): on (b)(6) 2024 initial tsh result was 0.613 and repeat result on (b)(6) 2024 was 0.6590 (reference range 0.700-5.700 uiu/ml).Sample sent an outside lab and on (b)(6) 2024 generated a result of 1.24 (reference range 0.60-4.84 uiu/ml).There was no reported impact to patient management.
Additional Manufacturer Narrative
Section a3a - sex was updated with additional information received from customer.
Event or Problem Description
The customer reported falsely decreased architect tsh and provided the following data for a 10 year old (sample id (b)(6)): on (b)(6) 2024 initial tsh result was 0.613 and repeat result on 30 apr was 0.6590 (reference range 0.700-5.700 uiu/ml).Sample sent an outside lab and on 27 apr generated a result of 1.24 (reference range 0.60-4.84 uiu/ml).There was no reported impact to patient management.
Event or Problem Description
The customer reported falsely decreased architect tsh and provided the following data for a 10 year old (sample id (b)(6)): on (b)(6) 2024 initial tsh result was 0.613 and repeat result on 30 apr was 0.6590 (reference range 0.700-5.700 uiu/ml).Sample sent an outside lab and on 27 apr generated a result of 1.24 (reference range 0.60-4.84 uiu/ml).There was no reported impact to patient management.
Additional Manufacturer Narrative
The complaint investigation included a review of data and information provided by the customer, search for similar complaints, 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.Device history review for the complaint lot did not identify any non-conformances, potential non-conformances, or deviations associated with the customer reported event.Ticket search by lot did not identify an increase in complaint activity for the complaint lot.Trending review did not identify a related trend regarding commonalities for complaint lot and customer reported event.The overall performance of the architect tsh reagent was reviewed using field data from customers.The review found that the median values are within the established limits.Labeling was reviewed and was found to address the customer reported issue.Based on the available information, no systemic issue or deficiency was identified for the architect tsh reagent lot 59319ud00.

• 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: 19298887
• Report Number: 3005094123-2024-00243
• Device Sequence Number: 5855527
• Product Code: JLW
• UDI-Device Identifier: 00380740014230
• UDI-Public: (01)00380740014230(17)250520(10)59319UD00
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• 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): 08/26/2024

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: 05/20/2025
• Device Catalogue Number: 07K62-25
• Device Lot Number: 59319UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/29/2024
• Supplement Date Received by Manufacturer: 05/14/2024; 08/01/2024
• Initial Report FDA Received Date: 05/13/2024
• Supplement Report FDA Received Date: 05/14/2024; 08/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/27/2024
• 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 I1000SR MOD, 01L86-01, (B)(6) ; ARC I1000SR MOD, 01L86-01, (B)(6) ; ARC I1000SR MOD, 01L86-01, (B)(6)
• Patient Age: 10 YR
• Patient Sex: Female