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	08/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed falsely decreased architect tsh results for one patient.The following data was provided (customer¿s normal range is 0.35-4.94 uiu/ml): initial result, on 07aug, was 0.0, repeat, after re-centrifuging, was 1.16, repeat was 0.01 uiu/ml.The patient was sent to another hospital and was tested on (b)(6) and the result, on an unknown platform, was 1.8.There was no impact to patient management reported.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.
Additional Manufacturer Narrative
The complaint investigation for falsely decreased architect tsh results included a search for similar complaints, the review of complaint text, trending data, labeling, and device history records.Return testing was not completed as returns were not available.Trending review determined no related trend for the issue for the product.Device history record review on lot 61378ud00 did not show any potential non-conformances or deviations.Labeling was reviewed and found to adequately address the issue under review.The median population result for the complaint lot is within established limits, indicating that the lot is performing acceptably in the field.Manufacturing documentation for the likely cause lot was reviewed and did not identify any issues.Based on the information provided and abbott diagnostics¿ complaint investigation, no systemic issue or deficiency with the architect tsh reagent, lot number 61378ud00, was identified.
Event or Problem Description
The customer observed falsely decreased architect tsh results for one patient.The following data was provided (customer¿s normal range is 0.35-4.94 uiu/ml): initial result, on 07aug, was 0.0, repeat, after re-centrifuging, was 1.16, repeat was 0.01 uiu/ml.The patient was sent to another hospital and was tested on 08aug and the result, on an unknown platform, was 1.8.There was no impact to patient management 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: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 20185067
• Report Number: 3005094123-2024-00470
• Device Sequence Number: 18355518
• Product Code: JLW
• UDI-Device Identifier: 00380740014230
• UDI-Public: (01)00380740014230(17)250805(10)61378UD00
• 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): 11/21/2024

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: 08/05/2025
• Device Catalogue Number: 07K62-25
• Device Lot Number: 61378UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/21/2024
• Supplement Date Received by Manufacturer: 11/21/2024
• Initial Report FDA Received Date: 09/10/2024
• Supplement Report FDA Received Date: 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2024
• 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, I1SR50320.; ARC I1000SR MOD, 01L86-01, I1SR50320.
• Patient Sex: Unknown