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

Catalog Number	03P36-25
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2025
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.Complete information from section a1.Patient identifier: sid (b)(6).
Event or Problem Description
The customer observed falsely elevated architect afp results for one patient who diagnosed with cancer.The following data was provided (normal range 1.09 - 8.04 ng/ml): (b)(6) 2025 initial architect afp result for sid (b)(6) was 568.23 ng/ml, repeated on (b)(6) 2025 and the result was 1.42 ng/ml.The patient then went to another laboratory where the result was reported as within normal limits (value unavailable).No impact to patient management was reported.
Additional Manufacturer Narrative
A complaint investigation was conducted for the architect afp reagent kit, list number 3p36-25, lot 75217fz00 to address the customer¿s observation of falsely elevated results.Review of tracking and trending by list number and by complaint lot did not identify any trends.Device history review did not identify issues associated with the customer¿s observation.The overall performance of architect afp reagents in the field was reviewed using data from customers worldwide.The review shows that the median patient result for the master lot falls within +/-1sd of the established baseline, indicating the reagent lot is performing acceptably on market.A review of the labelling addresses the customer¿s issue.Based on our investigation, no systemic issue or deficiency with the architect afp reagent lot 75217fz00 was identified.
Event or Problem Description
The customer observed falsely elevated architect afp results for one patient who diagnosed with cancer.The following data was provided (normal range 1.09 - 8.04 ng/ml): (b)(6) 2025 initial architect afp result for sid (b)(6) was 568.23 ng/ml, repeated on (b)(6) 2025 and the result was 1.42 ng/ml.The patient then went to another laboratory where the result was reported as within normal limits (value unavailable).No impact to patient management was reported.

• Brand Name: ARCHITECT AFP
• 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: 23878994
• Report Number: 3008344661-2025-00185
• Device Sequence Number: 14619880
• Product Code: LOK
• UDI-Device Identifier: 00380740081317
• UDI-Public: (01)00380740081317(17)260328(10)75217FZ00
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• 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): 02/06/2026

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: 03/28/2026
• Device Catalogue Number: 03P36-25
• Device Lot Number: 75217FZ00
• 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: 12/09/2025
• Supplement Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2025
• 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: ARC I2000SR INST, 03M74-02, (B)(6).; ARC I2000SR INST, 03M74-02, (B)(6).
• Patient Sex: Unknown