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

Model Number	3P36-25
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2022
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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.
Additional 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
• Common Device Name: 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
• Report Number: 3008344661-2022-00102
• Device Sequence Number: 12047329
• Product Code: LOK
• UDI-Device Identifier: 00380740081317
• UDI-Public: 00380740081317
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Followup
• Report Date (Section B): 11/08/2022

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: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/22/2022
• Supplement Date Received by Manufacturer: 09/06/2022; 10/20/2022
• Initial Report FDA Received Date: 08/31/2022
• Supplement Report FDA Received Date: 09/27/2022; 11/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2022
• 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: ARC I2K PROC MOD, 03M74-01, ISR03209; ARC I2K PROC MOD, 03M74-01, ISR03209; ARC I2K PROC MOD, 03M74-01, ISR03209
• Patient Sex: Unknown