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

Catalog Number	07P48-20
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported falsely decreased alinity i tsh results generated by the alinity i processing module for three patient samples.The physician questioned the initial results.The samples were repeated on a different analyzer, which yielded higher results.The following data was provided: customer¿s normal reference range: 0.5 to 5.0 miu/l.Patient #1: initial result = <0.10 miu/l, repeat result = 3.95 miu/l.Patient #3: initial result = <0.10 miu/l, repeat result = 1.94 miu/l.Patient #5: initial result = <0.10 miu/l, repeat result = 0.90 miu/l no impact to patient management was reported.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Complete information for section a1 patient identifier = patient 1, patient 3, and patient 5.
Additional Manufacturer Narrative
A complaint investigation was conducted for the alinity i tsh reagent lot 73537ud00.Review of tracking and trending by list number and by complaint lot did not identify any trends.Device history record review did not identify any nonconformances, potential nonconformances, or deviations associated with the complaint lot and complaint issue.Field data was reviewed to assess the performance of the alinity i tsh reagent.The median population result for the complaint lot is within established limits, indicating that the lot is performing acceptably in the field.The product labelling provides appropriate information related to the customer issue, which assists them in resolving their issue.The customer mentioned samples were too short.They reran and received accurate results.No malfunction or systemic issue was identified.Based on the information within the complaint record, the device met performance specifications and performed as intended at the customer site.
Event or Problem Description
The customer reported falsely decreased alinity i tsh results generated by the alinity i am processing module for three patient samples.The physician questioned the initial results.The samples were repeated on a different analyzer, which yielded higher results.The following data was provided: customer¿s normal reference range: 0.5 to 5.0 miu/l.Patient #1: initial result = <0.10 miu/l, repeat result = 3.95 miu/l.Patient #3: initial result = <0.10 miu/l, repeat result = 1.94 miu/l.Patient #5: initial result = <0.10 miu/l, repeat result = 0.90 miu/l 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: 23181026
• Report Number: 3005094123-2025-00490
• Device Sequence Number: 9991744
• Product Code: JLW
• UDI-Device Identifier: 00380740131142
• UDI-Public: (01)00380740131142(17)260824(10)73537UD00
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2025

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: 08/24/2026
• Device Catalogue Number: 07P48-20
• Device Lot Number: 73537UD00
• 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: 09/17/2025
• Supplement Date Received by Manufacturer: 11/14/2025
• Initial Report FDA Received Date: 09/30/2025
• Supplement Report FDA Received Date: 12/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2025
• 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