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

Model Number 07P9030

Device Problem High Test Results (2457)

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

Event Date 05/16/2023

Event Type  malfunction  

Event Description

The customer reported falsely elevated alinity i afp results for one patient sample.The customer was unable to provide the patient¿s medical history and information.The following data was provided: on (b)(6) 2023 sid (b)(6).Initial result = 20.15 ng/ml result on different module (method unknown) = 2.1 repeat result on the same analyzer = 2.63 ng/ml there was no impact to patient management reported.

Manufacturer Narrative

All available patient information was included.Additional patient details are not available.The complaint investigation for falsely elevated alinity i afp results included a search for similar complaints, and the review of complaint text, trending data, labeling, and device history records.Return testing was not performed as returns were not available.Data and information provided by the customer confirm the complaint issue without indication for any additional issues identified.The ticket search by lot number indicates the product lot is performing as expected.The ticket trending review of complaint data did not identify any trends regarding commonalities for lot number and complaint issue.A review of the labeling addresses the customer's issue.The field data analysis shows that the median patient result for lot 45424fn00 falls within 2sd of the established baseline, indicating the reagent lot is performing acceptably on market.The device history record review was performed on lot 45424fn00, which did not show any related potential non-conformances, deviations, or non-conformances.Based on the investigation, no systemic issue of product deficiency was identified for the alinity i afp reagent lot 45424fn00.

• 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: 17035169
• MDR Text Key: 316289646
• Report Number: 3008344661-2023-00097
• Device Sequence Number: 1
• Product Code: LOK
• UDI-Device Identifier: 00380740130824
• UDI-Public: 00380740130824
• 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
• Report Date: 05/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/11/2023
• Device Model Number: 07P9030
• Device Catalogue Number: 07P90-30
• Device Lot Number: 45424FN00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2022
• 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, AI23185