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	10/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.A1 patient identifier: sample id's are (b)(6).
Event or Problem Description
The customer observed falsely elevated alinity i afp for one patient.The following results were provided (reference range <=8.8 ug/l): on (b)(6) 2025, sid (b)(6), initial afp result (b)(6) = 559.12 ug/l; (b)(6) 2025, another sample was collected, sid (b)(6), initial result (b)(6) = 6.37 ug/l; (b)(6) 2025, repeat result= 5.78 ug/l, (b)(6) 2025, repeat result on another analyzer (b)(6 )= 5.69 ug/l.Additional results provided: ca125 result= 3.6 u/ml; cea result= 1.00 ug/l there was no impact to patient management reported.
Additional Manufacturer Narrative
The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, device history record review, field data review and labeling review.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 an increase in complaint activity related to the complaint issue.Additionally, an increase in complaint activity was not identified for reagent lot: 73014fz00.A device history record review did not identify any related potential non-conformance's, deviations, or non-conformance's associated with the complaint lot.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 is comparable with other lots in the field and within established baselines, confirming no systemic issue for the lot.Labeling was reviewed which adequately addresses the current issue.In this case, sample integrity issues at the time of testing could have contributed to the customer¿s observation.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 observed falsely elevated alinity i afp for one patient.The following results were provided (reference range <=8.8 ug/l): on (b)(6) 2025, sid: (b)(6), initial afp result (b)(6) = 559.12 ug/l; on (b)(6) 2025, another sample was collected, sid: (b)(6), initial result (b)(6) = 6.37 ug/l; on (b)(6) 2025, repeat result= 5.78 ug/l, on (b)(6) 2025, repeat result on another analyzer (b)(6) = 5.69 ug/l.Additional results provided: (b)(6) result= 3.6 u/ml; cea result= 1.00 ug/l there was no impact to patient management 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: 23421164
• Report Number: 3008344661-2025-00153
• Device Sequence Number: 18203299
• 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): 11/24/2025

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: 01/20/2026
• 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: 10/10/2025
• Supplement Date Received by Manufacturer: 11/19/2025
• Initial Report FDA Received Date: 10/29/2025
• Supplement Report FDA Received Date: 11/24/2025
• 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