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	11/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed falsely decreased alinity i tsh results for a 64-year-old female patient.The following data was provided: sample id (b)(6) result, on (b)(6) 2025, was 4.3879 uiu/ml.The patient was previously tested on (b)(6) 2025, and the result was 10.69 uiu/ml.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 alinity i tsh results included a search for similar complaints, the review of complaint text, trending data, labeling, and device history records.Historical performance of the complaint lot 77030ud00 was evaluated using worldwide field data.The median population result for the complaint lot is within established limits, indicating that the lot is performing acceptably in the field.A review of tracking and trending for the product and the lot number did not identify an increase in complaint activity.Device history record review on the lot number 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 complaint 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 77030ud00, was identified.
Event or Problem Description
The customer observed falsely decreased alinity i tsh results for a 64-year-old female patient.The following data was provided: sample id (b)(6) result, on (b)(6) 2025, was 4.3879 uiu/ml.The patient was previously tested on (b)(6) 2025, and the result was 10.69 uiu/ml.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: 23717704
• Report Number: 3005094123-2025-00621
• Device Sequence Number: 8901437
• Product Code: JLW
• UDI-Device Identifier: 00380740131159
• UDI-Public: (01)00380740131159(17)261204(10)77030UD00
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 12/17/2025

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 Catalogue Number: 07P48-30
• Device Lot Number: 77030UD00
• 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: 11/17/2025
• Supplement Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2025
• 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, (B)(6).; ALNTY I PROCESSING MODU, 03R65-01, (B)(6).
• Patient Age: 64 YR
• Patient Sex: Female