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

Catalog Number 07P90-77

Device Problem High Test Results (2457)

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

Event Date 04/25/2023

Event Type  malfunction  

Event Description

The customer observed falsely elevated alinity i afp results for two samples.The following data was provided: sample 1 initial result 10.33 ng/ml, repeated 2.46 and 2.47 ng/ml.Sample 2 initial result 14.32 ng/ml, repeated 3.14 ng/ml.(the reference range of afp is 0 - 8.78 ng/ml).No impact to patient management was reported.

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Manufacturer Narrative

New information added to the ticket 29may2023.The customer clarified that the patient was not pregnant or diagnosed with cancer.Data and information provided by the customer confirms the customer's issue without indication for any additional issues identified.The ticket search by lot number indicates that the product lot is performing as expected.Return testing was not performed as returns were not available.Device history record review was performed on lot 45424fn01, which did not show any potential non-conformances, deviations, or non-conformances.Trending review did not identify any trends.A review of the instrument data reporting system reports shows that the median patient result for lot 45424fn00 falls within 2 sd of the established baseline, indicating the reagent lot is performing acceptably on market.A review of the labelling addresses the customer's issue.A cross functional team review determined this event is deemed off label use as the customer used the assay contrary to product labelling (intended use).Per product labeling, the assay should not be used as a cancer screening test.Based on the investigation, no systemic issue or deficiency of the alinity i afp assay was identified.

Event Description

The customer observed falsely elevated alinity i afp results for two samples.The following data was provided: sample 1 initial result 10.33 ng/ml, repeated 2.46 and 2.47 ng/ml sample 2 initial result 14.32 ng/ml, repeated 3.14 ng/ml (the reference range of afp is 0 - 8.78 ng/ml).No impact to patient management was reported.

• 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: 16854718
• MDR Text Key: 314398879
• Report Number: 3008344661-2023-00087
• Device Sequence Number: 1
• Product Code: LOK
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 06/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2023
• 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 Catalogue Number: 07P90-77
• Device Lot Number: 45424FN01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/29/2023
• 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, (B)(6); ALNTY I PROCESSING MODU, 03R65-01, (B)(6)