MAUDE Adverse Event Report: ABBOTT IRELAND 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 02/27/2023

Event Type  malfunction  

Manufacturer Narrative

Patient identifier: complete sid is (b)(6).Initial reporter name and address 1: complete address is (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed falsely elevated alinity i afp result for one patient.The customer does not have any information pertaining to the clinical history on this patient.The sample was repeated several times which confirmed the lower result.The following data was provided: (b)(6) 2023 sid (b)(6) initial result = 39.28 ng/ml.(b)(6) 2023 sid (b)(6) repeat results = 8.02, 8.08, 8.03, 8.02, 7.86, 7.86 ng/ml.No impact to patient management was reported.

Manufacturer Narrative

The complaint investigation for falsely elevated alinity i 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.Data and information provided by the customer were reviewed and support the complaint issue.Ticket search by lot indicates the reagent lot is performing as expected for this product.Trending review did not identify any trends for the issue for the product.Device history record review did not identify any non-conformances or deviations with lot 44843fn00 and complaint issue.The overall performance of the alinity i afp reagent lot 44843fn00 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.Labeling was reviewed and sufficiently addresses the customer's issue.Based on this investigation, no systemic issue or deficiency was identified for the alinity i afp reagent lot 44843fn00.

• 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: 16593243
• MDR Text Key: 312032863
• Report Number: 3008344661-2023-00076
• 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: 04/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/25/2023
• Device Catalogue Number: 07P90-21
• Device Lot Number: 44843FN00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2022
• 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)