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

Catalog Number	07P90-20
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A1 patient identifier: complete list of sample id's are (b)(6).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 elevated alinity i afp results for one patient.The patient was repeated on multiple instruments with lower results.The following data was provided: (afp reference value at facility: 0.9-8.8 ng/ml).Sid (b)(6); initial alinity afp result processed on (b)(6) 2025 on serial number (b)(6) = 39.50 ng/ml retested on (b)(6) 2025 on (b)(6) = <2.0 ng/ml and on (b)(6) = <2.00 ng/ml new specimen same patient sid (b)(6) processed on (b)(6) 2025 results from alinity i instrument serial number (b)(6) = <2.00 ng/ml and <2.00 ng/ml and processed on (b)(6) = <2.0 ng/ml no impact to patient management was 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, labeling review, device history record review, and field data review.Return testing was not completed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.The ticket search by lot indicates that the complaint lot performs as expected for this product.Ticket trending review did not identify any increase in complaints for the complaint issue.Device history review did not identify any non-conformances, potential non-conformances or deviations associated with complaint lot number and complaint issue.The overall performance of the alinity i afp reagents in the field was reviewed using data gathered from customers worldwide.Review shows that the median patient result for the lot 64390fz00 is comparable with other lots in the field confirming no systemic issue for the lot.Labeling was reviewed and sufficiently addresses the customer¿s issue.Based on the investigation, no systemic issue or deficiency of the alinity i afp reagent kit, list number 07p9020, lot 64390fz00 was identified.
Event or Problem Description
The customer observed a falsely elevated alinity i afp results for one patient.The patient was repeated on multiple instruments with lower results.The following data was provided: (afp reference value at facility: 0.9-8.8 ng/ml) sid (b)(6) initial alinity afp result processed on (b)(6) 2025 on serial number (b)(6) = 39.50 ng/ml retested on (b)(6) 2025 on (b)(6) = <2.0 ng/ml and on (b)(6) = <2.00 ng/ml new specimen same patient sid (b)(6) processed on (b)(6) 2025 results from alinity i instrument serial number (b)(6) = <2.00 ng/ml and <2.00 ng/ml and processed on (b)(6) = <2.0 ng/ml 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: 21561728
• Report Number: 3008344661-2025-00025
• Device Sequence Number: 4430463
• Product Code: LOK
• UDI-Device Identifier: 00380740130817
• UDI-Public: (01)00380740130817(17)250508(10)64390FZ00
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: P120008
• 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): 04/02/2025

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: 05/08/2025
• Device Catalogue Number: 07P90-20
• Device Lot Number: 64390FZ00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/15/2025
• Supplement Date Received by Manufacturer: 03/31/2025
• Initial Report FDA Received Date: 03/10/2025
• Supplement Report FDA Received Date: 04/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/11/2024
• 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
• 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: Male