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	08/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being filed on an international product, list number 07p48-30 that has a similar product distributed in the us, list number 07p48, with 510k number k983442.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed a falsely depressed alinity i thyroid stimulating hormone (tsh) result for one patient.The sample was higher by another method.The following data provided: sid (b)(6), alinity tsh result = 3.01 reference range = 0.37-4.4 uiu/ml.Roche result (other lab) = 5.2 and 5.1 reference range = 0.27-4.2 uiu/ml.No impact to patient management was reported.
Event or Problem Description
The customer observed a falsely depressed alinity i thyroid stimulating hormone (tsh) result for one patient.The sample was higher by another method.The following data provided: sid (b)(6), alinity tsh result = 3.01 reference range = 0.37-4.4 uiu/ml.Roche result (other lab) = 5.2 and 5.1 reference range = 0.27-4.2 uiu/ml.No impact to patient management was reported.
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 reagent lot 75094ud00 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 75094ud00 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 diagnostic¿s complaint investigation, no systemic issue or deficiency with the alinity i tsh reagent, lot number 75094ud00, was identified.

• 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: 23051810
• Report Number: 3005094123-2025-00454
• Device Sequence Number: 9824943
• Product Code: JLW
• UDI-Device Identifier: 00380740131159
• UDI-Public: (01)00380740131159(17)260925(10)75094UD00
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• 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): 10/17/2025

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 Expiration Date: 09/25/2026
• Device Catalogue Number: 07P48-30
• Device Lot Number: 75094UD00
• 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: 09/03/2025
• Supplement Date Received by Manufacturer: 10/10/2025
• Initial Report FDA Received Date: 09/15/2025
• Supplement Report FDA Received Date: 10/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/10/2025
• 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: Unknown