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

Catalog Number	03P36-78
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/30/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: ALPHA-FETOPROTEIN
• Manufacturer (Section D): ABBOTT IRELAND; diagnostics division; finisklin business park; sligo NA ; EI NA
• MDR Report Key: 8884410
• Report Number: 3008344661-2019-00098
• Device Sequence Number: 2447655
• Product Code: LOK
• UDI-Device Identifier: 00380740112400
• UDI-Public: 00380740112400
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P120008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2019

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: 12/19/2019
• Device Catalogue Number: 03P36-78
• Device Lot Number: 96121FN00
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/23/2019
• Supplement Date Received by Manufacturer: 10/09/2019
• Initial Report FDA Received Date: 08/12/2019
• Supplement Report FDA Received Date: 10/11/2019
• 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: ARCHITECT I2000SR ANALYZER LIST 03M74-02; ARCHITECT I2000SR ANALYZER LIST 03M74-02; SERIAL (B)(4).; SERIAL (B)(4).