MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ALINITY I TSH REAGENT KIT; RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE

Catalog Number	07P48-30
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed falsely decreased alinity i tsh results for two patients.The following data was provided (customer¿s normal range is 0.35-4.94 miu/l): sample id (b)(6) initial result, on 28mar2025 with analyzer serial number (b)(6), was 0.273, repeat result, on 31mar2025 with analyzer serial number (b)(6), was 34.642 miu/l.Sample id (b)(6) initial result, on 29mar2025 with analyzer serial number (b)(6), was 1.523, repeat result, on 31mar2025, was 39.067 miu/l.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.Section a1: patient identifier complete entry: sample id (b)(6) and sample id (b)(6) all available patient information was included.Additional patient details are not available.
Additional Manufacturer Narrative
The complaint investigation for falsely decreased alinity i 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.Historical performance of reagent lot 70200ud00 was evaluated using worldwide field data.Review shows that the median patient result for the lot is within established limits and comparable with other lots in the field, confirming no systemic issue for the lot.A review of tracking and trending for the product and the likely cause lot did not identify an increase in complaint activity.Device history record review on lot 70200ud00 did not show any potential non-conformances or deviations.Labeling was reviewed and found to adequately address the issue under review.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 alinity i tsh reagent, lot number 70200ud00, was identified.
Event or Problem Description
The customer observed falsely decreased alinity i tsh results for two patients.The following data was provided (customer¿s normal range is 0.35-4.94 miu/l): sample id (b)(6) initial result, on (b)(6) 2025 with analyzer serial number (b)(6), was 0.273, repeat result, on (b)(6) 2025 with analyzer serial number (b)(6), was 34.642 miu/l sample id (b)(6) initial result, on (b)(6) 2025 with analyzer serial number (b)(6), was 1.523, repeat result, on (b)(6) 2025, was 39.067 miu/l.There was no impact to patient management reported.

• Brand Name: ALINITY I 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: 21901189
• Report Number: 3005094123-2025-00192
• Device Sequence Number: 4059405
• Product Code: JLW
• UDI-Device Identifier: 00380740131159
• UDI-Public: (01)00380740131159(17)260504(10)70200UD00
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 05/13/2025

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: 05/04/2026
• Device Catalogue Number: 07P48-30
• Device Lot Number: 70200UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2025
• Supplement Date Received by Manufacturer: 05/12/2025
• Initial Report FDA Received Date: 04/24/2025
• Supplement Report FDA Received Date: 05/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/27/2024
• 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: ALNTY I PROCESSING MODU, 03R65-01, AI03072; ALNTY I PROCESSING MODU, 03R65-01, AI03072; ALNTY I PROCESSING MODU, 03R65-01, AI03182; ALNTY I PROCESSING MODU, 03R65-01, AI03182
• Patient Sex: Unknown