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

Catalog Number 03P36-36

Device Problem Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/01/2023

Event Type  malfunction  

Event Description

The customer observed falsely decreased architect afp results generated on the architect i2000sr processing module for a 88 year old male patient with suspected liver cancer.(b)(6) 2021: afp= 774.(b)(6) 2021:afp = 1122.(b)(6) 2022:afp = 1327.The measurements from 2021 and 2022 were performed on the architect.The patient received no treatment but the values went down this year.(b)(6) 2023: afp = 2.(b)(6) 2023:afp = 2.0.No impact to patient management was reported.

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Completed information for section e1 phone number : (b)(6).

Manufacturer Narrative

The complaint investigation for falsely depressed architect afp results 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.A review of tracking and trending did not identify any trends for the complaint issue.The device history record review was performed on list 3p36 as the lot is unknown.The search did not show any potential non-conformances, deviations, or non-conformances associated with the complaint issue.Customer field data was used to assess the performance of the architect afp assay using worldwide data.Review shows that the median patient result for list 3p36 is within established limits and comparable, confirming no systemic issue.Labeling was reviewed and found to adequately address the issue.Based on the investigation, no systemic issue or deficiency of the architect afp assay was identified.All available patient information was included.Additional patient details are not available.

Event Description

The customer observed falsely decreased architect afp results generated on the architect i2000sr processing module for a 88 year old male patient with suspected liver cancer.Oct2021: afp= 774.Dec2021:afp = 1122.Feb2022:afp = 1327.The measurements from 2021 and 2022 were performed on the architect.The patient received no treatment but the values went down this year.Apr2023: afp = 2.Jun2023:afp = 2.0.No impact to patient management was reported.

• Brand Name: ARCHITECT AFP REAGENT KIT
• Type of Device: 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: 17434788
• MDR Text Key: 320144520
• Report Number: 3008344661-2023-00137
• Device Sequence Number: 1
• Product Code: LOK
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P120008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03P36-36
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 88 YR
• Patient Sex: Male