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

Model Number	07P9030
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2023
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 3008344661-2023-00097
• Device Sequence Number: 12487156
• Product Code: LOK
• UDI-Device Identifier: 00380740130824
• UDI-Public: 00380740130824
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P120008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/17/2023
• Initial Report FDA Received Date: 05/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALNTY I PROCESSING MODU, 03R65-01, AI23185
• Patient Sex: Unknown