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

Catalog Number 07P90-21

Device Problem High Test Results (2457)

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

Event Date 08/14/2023

Event Type  malfunction  

Event Description

The customer observed a falsely elevated alinity i afp result for a patient sample at a mammary gland outpatient clinic.(afp reference value at facility: 10 ng/ml) (b)(6) 2023 alinity afp result was 18 ng/ml, outsourced to srl and total aft was 9.9 ng/ml (roughly the same results as 3 years ago) the customer reported the patient is a breast surgery patient.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.All available patient information was included.Additional patient details are not available.

Manufacturer Narrative

The complaint investigation for falsely elevated alinity i 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 related trends for the product for the issue.The device history record review on lot 49160fn00 did not show any potential non-conformances, deviations, or non-conformances associated with the complaint issue.Field data was used to assess the performance of the alinity i afp assay.Review shows that the median patient result for lot 49160fn00 falls within 1sd of the established baseline, indicating the reagent lot is performing acceptably on market.Labeling was reviewed and found to adequately address the issue under review.Based on the investigation, no systemic issue or deficiency of the alinity i afp for lot number 49160fn00 was identified.All available patient information was included.Additional patient details are not available.

Event Description

The customer observed a falsely elevated alinity i afp result for a patient sample at a mammary gland outpatient clinic.(afp reference value at facility: 10 ng/ml) on (b)(6) 2023 alinity afp result was 18 ng/ml, outsourced to srl and total aft was 9.9 ng/ml (roughly the same results as 3 years ago).The customer reported the patient is a breast surgery patient.No impact to patient management was reported.

• Brand Name: ALINITY I 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: 17718595
• MDR Text Key: 323048012
• Report Number: 3008344661-2023-00168
• 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: 09/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/23/2024
• Device Catalogue Number: 07P90-21
• Device Lot Number: 49160FN00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY I PROCESSING MODU, 03R65-01, (B)(6); ALNTY I PROCESSING MODU, 03R65-01, (B)(6)
• Patient Sex: Female