MAUDE Adverse Event Report: ABBOTT IRELAND ARCHITECT AFP; ALPHA-FETOPROTEIN

Catalog Number 03P36-78

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/30/2019

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.

Event Description

The customer reported a falsely elevated architect afp result on one patient.Results provided: (b)(6) 2019 sid (b)(6) = 33.06 ng/ml / 3.12 ng/ml.No impact to patient management was reported.

Manufacturer Narrative

A review of tickets was performed for the likely cause architect afp reagent lot number 96121fn00.The ticket search determined that there is normal complaint activity for this lot number.Testing was performed in-house using a retained kit of lot# 96121fn00 and all specifications were met, indicating the lot is performing acceptably.A review of the manufacturing documentation did not identify any issues associated with the customers observation.Historical performance in the field of reagent lot 96121fn00 using world wide data through abbottlink was evaluated.The patient median result for this lot was analyzed and found to be within established baselines and confirms no systemic issues for this lot.Return testing was not completed as returns were not available.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation no product deficiency was identified for the architect afp lot# 96121fn00 assay.Correction:catalog # edited from 03p36-35 to 03p36-78.

• Brand Name: ARCHITECT AFP
• Type of Device: ALPHA-FETOPROTEIN
• Manufacturer (Section D): ABBOTT IRELAND; diagnostics division; finisklin business park; sligo NA ; EI NA
• MDR Report Key: 8884410
• MDR Text Key: 160370330
• Report Number: 3008344661-2019-00098
• Device Sequence Number: 1
• Product Code: LOK
• UDI-Device Identifier: 00380740112400
• UDI-Public: 00380740112400
• Combination Product (y/n): N
• PMA/PMN Number: P120008
• 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: 10/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/19/2019
• Device Catalogue Number: 03P36-78
• Device Lot Number: 96121FN00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR ANALYZER LIST 03M74-02; ARCHITECT I2000SR ANALYZER LIST 03M74-02; SERIAL (B)(4).; SERIAL (B)(4).