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	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
All available patient information was included.Additional patient details are not available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed imprecise alinity i tsh results on a newborn (dob on (b)(6) 2025) female patient.The result provided were: sid: (b)(6) initial= 5.1951 uiu/ml /repeated from primary tube=2.8696 uiu/ml.Repeated after recentrifuged and from aliquot=4.3479 uiu/ml.Repeated=5.8104 uiu/ml.Laboratory reference range for tsh=0.35 to 4.94 uiu/ml.Additional information provided: ft3=2.69 pg/ml; ft4=27.4 pmol/l.There was no reported impact to patient management.
Event or Problem Description
The customer observed imprecise alinity i tsh results on a newborn (dob (b)(6) 2025) female patient.The result provided were: sid (b)(6) initial=5.1951 uiu/ml /repeated from primary tube=2.8696 uiu/ml.Repeated after recentrifuged and from aliquot=4.3479 uiu/ml.Repeated=5.8104 uiu/ml.Laboratory reference range for tsh=0.35 to 4.94 uiu/ml.Additional information provided: ft3=2.69 pg/ml; ft4=27.4 pmol/l.There was no reported impact to patient management.
Additional Manufacturer Narrative
The complaint evaluation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review and field data of alinity i tsh reagent lot number 67049ud00.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.Review of tracking and trending for alinity i tsh assay did not identify an increase in complaint activity related to the complaint issue.Additionally, an increase in complaint activity was not identified for reagent lot 67049ud00.Historical performance of the alinity i tsh reagents in the field was reviewed using data gathered from customers worldwide.The median population result for the complaint lot is within established limits, indicating that the lot is performing acceptably in the field.Device history record review did not identify any non-conformances or deviations with the complaint lot and complaint issue.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation no product deficiency was identified for the alinity i tsh, reagent lot 67049ud00.

• 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: 23393783
• Report Number: 3005094123-2025-00540
• Device Sequence Number: 13254205
• Product Code: JLW
• UDI-Device Identifier: 00380740131142
• UDI-Public: (01)00380740131142(17)260108(10)67049UD00
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• 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): 12/05/2025

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: 01/08/2026
• Device Catalogue Number: 07P48-20
• Device Lot Number: 67049UD00
• 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: 10/10/2025
• Supplement Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 10/27/2025
• Supplement Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/24/2024
• 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
• Usage of Device: Unknown
• 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: 3 DA
• Patient Sex: Female