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

Model Number	3P36-25
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed falsely elevated architect afp results on one patient.The results provided were: (b)(6) 2023, sid (b)(6), initial= 20.75 ng/ml /repeated twice= < 2.0 ng/ml /repeated on (b)(6) 2023, =18 ng/ml /repeated in 5 replicates= < 2 ng/ml.Laboratory reference range for afp= 0.0 to 10 ng/ml.The precision study data provided for troubleshooting purpose.There was no reported impact to patient management.
Additional Manufacturer Narrative
Complete information for section a patient information, 1.Patient identifier = sid= (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Updated postal code e1=to 01246 from 1246.
Event or Problem Description
The customer observed falsely elevated architect afp results on one patient.The results provided were: (b)(6) 2023 sid (b)(6) initial= 20.75 ng/ml /repeated twice= < 2.0 ng/ml /repeated on (b)(6) 2023=18 ng/ml /repeated in 5 replicates= < 2 ng/ml.Laboratory reference range for afp= 0.0 to 10 ng/ml.The precision study data provided for troubleshooting purpose.There was no reported impact to patient management.
Additional Manufacturer Narrative
The complaint evaluation 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 of architect afp reagent lot number 45380fn00.The ticket search determined that there is as expected complaint activity for the likely cause lot.A review of 12 months of complaint data did not identify any non-statistical trends or any atypical complaint activity associated with this described issue.Trending review determined no trend for the issue for the product.Return testing was not completed as returns were not available.Historical performance of reagent lot 45380fn00 were evaluated using worldwide data from abbottlink.The patient median values obtained with the complaint lot 45380fn00 are within established limits, indicating the reagent lot is performing acceptably on market.Device history record review did not identify any non-conformances or deviations with the complaint lot and complaint issue.This event is deemed off label use as the customer used the assay contrary to product labelling (intended use).Based on the investigation no product deficiency was identified for the architect afp reagent lot number 45380fn00.

• 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: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 16954419
• Report Number: 3008344661-2023-00095
• Device Sequence Number: 17895679
• Product Code: LOK
• UDI-Device Identifier: 00380740081317
• UDI-Public: 00380740081317
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• 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): 06/09/2023

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: 10/06/2023
• Device Model Number: 3P36-25
• Device Catalogue Number: 03P36-25
• Device Lot Number: 45380FN00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/29/2023
• Supplement Date Received by Manufacturer: 06/08/2023
• Initial Report FDA Received Date: 05/18/2023
• Supplement Report FDA Received Date: 06/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2022
• 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