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

Catalog Number	07P90-30
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer reported false elevated alinity i afp and provided the following data: on (b)(6) 2025, sample (b)(6) initial result was 83.7 ug/land repeat result on another analyzer was <2 ug/l.No further patient data was provided.Per the customer discrepant results were not reported out to the medical provider.There was no reported impact to patient management.
Event or Problem Description
The customer reported false elevated alinity i afp and provided the following data: on (b)(6) 2025, sample (b)(6) initial result was 83.7 ug/land repeat result on another analyzer was <2 ug/l.No further patient data was provided.Per the customer discrepant results were not reported out to the medical provider.There was no reported impact to patient management.
Additional Manufacturer Narrative
The complaint investigation 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.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.Review of tracking and trending for the alinity i afp reagent kit did not identify an increase in complaint activity related to the complaint issue.A review of the device history record did not identify any nonconformances or deviations with the complaint lot.The overall performance of alinity i afp reagent kit in the field was reviewed using data gathered from customers worldwide.The patient median values for lot 67628fz00 are comparable with other lots in the field confirming no systemic issue for the lot.Labeling was reviewed and adequately addresses the issue under review.Based on the investigation, no systemic issue or product deficiency of the alinity i afp reagent kit lot 67628fz00 was identified.

• 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: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 21819378
• Report Number: 3008344661-2025-00040
• Device Sequence Number: 12728994
• Product Code: LOK
• UDI-Device Identifier: 00380740130824
• UDI-Public: (01)00380740130824(17)250821(10)67628FZ00
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: P120008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2025

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: 08/21/2025
• Device Catalogue Number: 07P90-30
• Device Lot Number: 67628FZ00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2025
• Supplement Date Received by Manufacturer: 05/12/2025
• Initial Report FDA Received Date: 04/10/2025
• Supplement Report FDA Received Date: 05/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2024
• 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, (B)(6) ; ALNTY I PROCESSING MODU, 03R65-01, (B)(6)
• Patient Sex: Unknown