MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ARCHITECT AFP REAGENT KIT; 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	06/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a-1 patient identifier: complete sid is (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 falsely elevated architect afp result generated on the architect i1000sr processing for a patient.The sample was repeated and a lower result was obtained.The customer does not have any information regarding the patient¿s diagnosis.The following data was provided: (b)(6) 2024 sid (b)(6) initial result = 294.14 ng/ml.(b)(6) 2024 sid (b)(6) rerun result = 5.93 ng/ml.There was no impact to patient management reported.
Event or Problem Description
The customer observed falsely elevated architect afp result generated on the architect i1000sr processing for a patient.The sample was repeated and a lower result was obtained.The customer does not have any information regarding the patient¿s diagnosis.The following data was provided: (b)(6) 2024 sid (b)(6) initial result = 294.14 ng/ml.(b)(6) 2024 sid (b)(6) rerun result = 5.93 ng/ml.There was no impact to patient management reported.
Additional Manufacturer Narrative
The complaint investigation for falsely elevated architect afp result 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.The data and information provided by the customer were reviewed and support the complaint issue.A ticket search by lot indicates the reagent lot is performing as expected for this product.A review of the trending report did not identify any trends for the issue for the product.A review of the device history record did not identify any non-conformances or deviations with lot 58588fn00 and complaint issue.The historical performance of the architect afp reagent lot 58588fn00 in the field was reviewed using data gathered from customers worldwide.The median population result for the complaint lot is within the established limits which indicates that the lot is performing acceptably.A review of labeling was performed and found to sufficiently address the customer's issue.Based on this investigation, no systemic issue or deficiency was identified for the architect afp reagent lot 58588fn00.

• Brand Name: ARCHITECT 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: 19920734
• Report Number: 3008344661-2024-00090
• Device Sequence Number: 15265092
• Product Code: LOK
• UDI-Device Identifier: 00380740081317
• UDI-Public: (01)00380740081317(17)240912(10)58588FN00
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• 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): 10/23/2024

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: 09/12/2024
• Device Catalogue Number: 03P36-25
• Device Lot Number: 58588FN00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/17/2024
• Supplement Date Received by Manufacturer: 10/23/2024
• Initial Report FDA Received Date: 08/06/2024
• Supplement Report FDA Received Date: 10/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2023
• 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 I1SR REFURB-KOREA, 01L86-65, (B)(6); ARC I1SR REFURB-KOREA, 01L86-65, (B)(6)
• Patient Sex: Unknown