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	11/26/2023
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 decreased architect tsh result for one patient when compared to another platforms.The following data was provided: sid 7035 architect tsh result = 2.393 miu/l.27nov2023 roche tsh result = 32.30, ft4 result = 19.6.30nov2023 tosoh tsh result = 13.353 uiu/ml.Patient¿s previous results (one year prior): architect results = normal (no specific data provided) roche/beckman/siemens results: tsh was high, free t3 and free t4 were normal no impact to patient management was reported.
Event or Problem Description
The customer observed falsely decreased architect tsh result for one patient when compared to another platforms.The following data was provided: sid (b)(6) architect tsh result = 2.393 miu/l 27nov2023 roche tsh result = 32.30, ft4 result = 19.6 30nov2023 tosoh tsh result = 13.353 uiu/ml patient¿s previous results (one year prior): architect results = normal (no specific data provided) roche/beckman/siemens results: tsh was high, free t3 and free t4 were normal no impact to patient management was reported.
Additional Manufacturer Narrative
Section d4 - lot # was updated from unknown to 55171ud00.The complaint investigation for falsely decreased architect tsh results included a review of data and information provided by the customer, search for similar complaints, ticket trending review, device history record review, labeling review, and field data review.Return testing was not completed as returns were not available.The data and information provided by the customer were reviewed and support the complaint issue.A ticket search by lot indicates the reagent lot is performing as expected for this product.A review of the complaint trending report did not identify any trends for the issue for the product.A review of the device history record did not identify any non-conformances or deviations with the lot number 55171ud00 and complaint issue.The overall performance of the architect tsh reagent was reviewed using field data from customers worldwide.The median population result for lot 55171ud00 is within established limits, indicating that the lot is performing acceptably in the field.A review of labeling was performed and found to sufficiently address the customer¿s issue.Based on our investigation, no systemic issue or deficiency was identified with the architect tsh reagent, lot number 55171ud00.

• 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: 18349405
• Report Number: 3005094123-2023-00378
• Device Sequence Number: 17692748
• Product Code: JLW
• UDI-Device Identifier: 00380740014230
• UDI-Public: 00380740014230
• Combination Product (Y/N): N
• Initial Reporter Country: QA
• PMA/510(K) Number: K983442
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2024

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: 12/27/2024
• Device Catalogue Number: 07K62-25
• Device Lot Number: 55171UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/26/2023
• Supplement Date Received by Manufacturer: 01/11/2024
• Initial Report FDA Received Date: 12/18/2023
• Supplement Report FDA Received Date: 02/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2023
• 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 Sex: Unknown