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

Catalog Number 07P90-31

Device Problem High Test Results (2457)

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

Event Date 12/08/2022

Event Type  malfunction  

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.

Event Description

The customer observed falsely elevated alinity i afp results for one patient sample during a health screen.Results provided: (b)(6) 2022 afp initial result = 108.73 ng/ml, repeat result = 3.62 ng/ml additionally, the patient had the following test results: (b)(6) 2022 cea 1.88 ng/ml.(b)(6) 2022 ca19-9 6.10 u/ml.No impact to patient management was reported.

Manufacturer Narrative

The complaint investigation for false 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 trends for the complaint issue.Labeling was reviewed and found to adequately address the issue.Data from customers worldwide was used to assess the performance of the alinity i afp assay.The median patient result for lot 39072fn00 is within established limits and comparable with other lots in the field, which indicates acceptable product performance.Device history record review on lot 39072fn00 did not show any potential non-conformances, deviations, or non-conformances associated with the complaint issue.Based on the investigation, no systemic issue or deficiency of the alinity i afp assay for lot number 39072fn00 was identified.All available patient information was included.Additional patient details are not available.

• Brand Name: ALINITY I AFP REAGENT KIT
• Type of Device: KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
• Manufacturer (Section D): ABBOTT IRELAND; finisklin business park; sligo F91VY 44; EI F91VY44
• Manufacturer (Section G): ABBOTT IRELAND; 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: 16067254
• MDR Text Key: 308493198
• Report Number: 3008344661-2022-00191
• 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: 01/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/19/2023
• Device Catalogue Number: 07P90-31
• Device Lot Number: 39072FN00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2022
• 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)