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	11/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a patient information: no additional information was provided.An evaluation is in process.A followup report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed depressed alinity i tsh results compared with another method.Sid: (b)(6).On (b)(6) 2025 alinity i tsh 3.8204 uiu/ml (reference range 0.35-4.94 uiu/ml).On (b)(6) 2025 alinity i tsh 4.0845 uiu/ml (reference range 0.35-4.94 uiu/ml).On (b)(6) 2025 clia centaur method 14.457 uiu/ml (reference range 0.55-4.78 uiu/ml).Total t3 and total t4 are normal.Per the patient, there is no clinical history or on any medication.No impact to patient management was reported.
Additional Manufacturer Narrative
The data and information provided by the customer were reviewed and supported the complaint issue without indication of any additional issues.A search for similar complaints did not identify an increase in complaint activity for lot 71332ud00.A review of tracking and trending for the alinity i tsh assay did not identify any trends related to the complaint issue.A review of the device history record did not identify any non-conformances, potential non-conformances or deviations with lot number 71332ud00 and the complaint issue.The overall performance of the alinity i tsh reagent was reviewed using field data from customers worldwide.The median population result for the complaint lot is within established limits, indicating that the lot is performing acceptably.A review of labeling was performed and found to sufficiently address the customer's issue.Based on the investigation, no systemic issue or deficiency was identified with the alinity i tsh reagent, lot number 71332ud00.
Event or Problem Description
The customer observed depressed alinity i tsh results compared with another method.Sid(b)(6) (b)(6) 2025 alinity i tsh 3.8204 uiu/ml (reference range 0.35-4.94 uiu/ml).(b)(6) 2025 alinity i tsh 4.0845 uiu/ml (reference range 0.35-4.94 uiu/ml).(b)(6) 2025 clia centaur method 14.457 uiu/ml (reference range 0.55-4.78 uiu/ml).Total t3 and total t4 are normal.Per the patient, there is no clinical history or on any medication.No impact to patient management was 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: 23758274
• Report Number: 3005094123-2025-00634
• Device Sequence Number: 10117537
• Product Code: JLW
• UDI-Device Identifier: 00380740131159
• UDI-Public: (01)00380740131159(17)250611(10)71332UD00
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 01/02/2026

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: 06/11/2025
• Device Catalogue Number: 07P48-30
• Device Lot Number: 71332UD00
• 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: 11/13/2025
• Supplement Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 01/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2025
• 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 Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian