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

Catalog Number 03P36-31

Device Problem High Test Results (2457)

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

Event Date 04/28/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Was this device serviced by a third party? no.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.(b)(6).All available patient information was included.Additional patient details are not available.

Event Description

The customer observed a falsely elevated architect afp result for one patient.The following data was provided: initial result was 40.98, repeat was 3.4 ng/ml.The patient¿s previous result was 3.3 ng/ml.There was no impact to patient management reported.

Manufacturer Narrative

The complaint investigation for falsely elevated architect afp results included a search for similar complaints, review of complaint text, trending data, labeling, and device history records.Return testing was not completed as returns were not available.Using worldwide field data, the performance of reagent lot 21162fn00 and associated sublots manufactured with the same material were evaluated and are performing similar to other reagent lots in the field confirming there was no systemic issue.Trending review determined no related trend for the issue for the product.Device history record review on lot 21162fn00 did not show any potential non-conformances or deviations.Labeling was reviewed and found to adequately address the issue under review.All specifications were met indicating that the lot is performing acceptably.Based on the information provided and abbott diagnostics¿ complaint investigation, no systemic issue or deficiency of the architect afp assay, lot number 21162fn00, was identified.This follow up is being submitted to include d8 and h6 information previously submitted using the h10 section in their respective fields.

• 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
• MDR Report Key: 11820578
• MDR Text Key: 281094422
• Report Number: 3008344661-2021-00106
• Device Sequence Number: 1
• Product Code: LOK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 06/11/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 10/12/2021
• Device Catalogue Number: 03P36-31
• Device Lot Number: 21162FN00
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/28/2021
• Initial Date FDA Received: 05/13/2021
• Supplement Dates Manufacturer Received: 06/11/2021
• Supplement Dates FDA Received: 06/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2K PROC MOD, 03M74-01, (B)(4); ARC I2K PROC MOD, 03M74-01, (B)(4)