MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ALINITY I AFP REAGENT KIT; KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS

Catalog Number	07P90-30
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a1 - patient identifier, a2 - age at time of event, a3a - sex: sid (b)(6) (59-year-old male): sid (b)(6) (83-year-old female): sid (b)(6) (64- year-old male): an evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer reported falsely elevated alinity i afp results generated by the alinity i processing module for three patients.No information was available regarding the patients¿ diagnoses.The samples were repeated, and lower results were obtained.The following data was provided: customer¿s reference range: =8.1 g/l sid (b)(6) (59-year-old male): 18nov2025 alinity i afp initial result = 42.4 g/l, repeat result = 2.9 g/l.Sid (b)(6) (83-year-old female): 18nov2025 alinity i afp initial result = 23.2 g/l, repeat result = 1.5 g/l.Sid (b)(6) (64- year-old male): 19nov2025 alinity i afp initial result = 20.1 g/l, repeat result = 12.6 g/l.No impact to patient management was reported.
Additional Manufacturer Narrative
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 the alinity i afp assay did not identify any trends related to the complaint issue.Additionally, no trends were identified for lot 73014fz00.A device history record review did not show any related potential non-conformances, deviations, or non-conformances for the complaint lot and issue.Customer field data was used to assess the performance of the alinity i afp assay using worldwide data.Review shows that the median patient result for the lot 73014fz00 was comparable with other lots in the field confirming no systemic issue for the lot.Labeling was reviewed which adequately addresses the current issue.Based on the investigation, no systemic issue or deficiency of the alinity i afp reagent lot 73014fz00 was identified.
Event or Problem Description
The customer reported falsely elevated alinity i afp results generated by the alinity i processing module for three patients.No information was available regarding the patients¿ diagnoses.The samples were repeated, and lower results were obtained.The following data was provided: customer¿s reference range: =8.1 g/l.Sid (b)(6) (59-year-old male): (b)(6) 2025 alinity i afp initial result = 42.4 g/l, repeat result = 2.9 g/l.Sid (b)(6) (83-year-old female): (b)(6) 2025 alinity i afp initial result = 23.2 g/l, repeat result = 1.5 g/l sid (b)(6) (64- year-old male): (b)(6) 2025 alinity i afp initial result = 20.1 g/l, repeat result = 12.6 g/l no impact to patient management was reported.

• Brand Name: ALINITY I AFP REAGENT KIT
• Common Device Name: KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION; finisklin business park; sligo F91VY 44; EI F91VY44
• Manufacturer (Section G): ABBOTT IRELAND DIAGNOSTICS DIVISION; finisklin business park; sligo F91VY 44; EI F91VY44
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 23757037
• Report Number: 3008344661-2025-00174
• Device Sequence Number: 10131564
• Product Code: LOK
• UDI-Device Identifier: 00380740130824
• UDI-Public: (01)00380740130824(17)260120(10)73014FZ00
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: P120008
• 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): 02/02/2026

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: 01/20/2026
• Device Catalogue Number: 07P90-30
• Device Lot Number: 73014FZ00
• 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: 11/24/2025
• Supplement Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 02/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/12/2025
• 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