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

Model Number 3P36-25

Device Problem Low Test Results (2458)

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

Event Date 06/10/2022

Event Type  malfunction  

Manufacturer Narrative

Patient identifier: sid (b)(6) and sid (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 depressed architect afp results for one patient.The initial result in question for sid (b)(6) on (b)(6) 2022 was 187.19 ui/ml.A new sample sid (b)(6) from (b)(6) 2022 generated a result of >1660.00, dilution 1:10 >16600.00, dilution 1:20 18584.24 ui/ml.The sample from (b)(4) 2022 (sid (b)(6)) was repeated on (b)(6) 2022 and the result was >1660.00, dilution 1:10 >16600.00, dilution 1:20 11463.05 ui/ml.No impact to patient management was reported.

Manufacturer Narrative

This follow up is being submitted to include the initial coding in section h6 for component code, type of investigation, investigation findings and investigation conclusions that were not included in the initial report.

Manufacturer Narrative

Data and information provided by the customer were reviewed and support the complaint issue.The ticket search by lot indicates that the reagent lot performs as expected for this product.Return testing was not performed as returns were not available.Device history record review was performed on lot 37040fn00, which did not show any potential non-conformances, deviations, or non-conformances.Trending review did not identify any trends for the complaint issue.Review of field data for the architect afp assays shows that the median patient result for lot 37040fn00 falls within 1sd of the established baseline, indicating the reagent lot is performing acceptably on market.As the expected result was obtained for a new sample draw and on repeat of the original sample, it is possible that reagent/sample integrity issues at the time of testing may have contributed to the false depressed result obtained.Details around specimen and reagent handling are outlined in the product package insert.A review of the labeling addresses the customer¿s issue.Per product labelling if the architect afp results are inconsistent with clinical evidence, additional testing is suggested to confirm the result.For diagnostic purposes, results should be used in conjunction with other data; e.G., symptoms, results of other tests, clinical impressions etc.Based on all reviewed data, we conclude that there is no product deficiency with the architect afp reagent identified in this complaint.

• Brand Name: ARCHITECT 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: 15327168
• MDR Text Key: 302281380
• Report Number: 3008344661-2022-00102
• Device Sequence Number: 1
• Product Code: LOK
• UDI-Device Identifier: 00380740081317
• UDI-Public: 00380740081317
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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,Followup
• Report Date: 11/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/27/2023
• Device Model Number: 3P36-25
• Device Catalogue Number: 03P36-25
• Device Lot Number: 37040FN00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2K PROC MOD, 03M74-01, ISR03209; ARC I2K PROC MOD, 03M74-01, ISR03209; ARC I2K PROC MOD, 03M74-01, ISR03209