MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ARCHITECT TOTAL PSA; TOTAL, PROSTATE SPECIFIC AG (NONCOMPLEXED/COMPLEXED) FOR DET OF PROSTATE CANCER

Catalog Number 07K70-27

Device Problem High Test Results (2457)

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

Event Date 09/12/2023

Event Type  malfunction  

Manufacturer Narrative

This report is being filed on an international product, list number 7k70 and there is a similar product distributed in the us, list number 6c06.All available patient information was included.Additional patient details are not available.The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review, and field data review.Return testing was not completed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.The ticket search by lot indicates that the reagent complaint lot performs as expected for this product.Ticket trending review did not identify any trends.Device history review did not identify any non-conformances or deviations with the complaint lot.The overall performance of the architect total psa reagents in the field was reviewed using data gathered from customers worldwide.The review of field data determined reagent lot 49488fn00 is performing acceptably on market.Labeling was reviewed and sufficiently addresses the customer¿s issue.Based on the investigation, no systemic issue or deficiency of the architect total psa lot 49488fn00.

Event Description

The customer reported falsely elevated architect total psa, specifically, the customer communicated that they expected the psa results to have decreased and reported patient testosterone levels have decreased.The customer provided the following data for 1 patient: (b)(6) 2023.Initial result was 7.732 ng/ml.The customer repeated the results with dilution and reported poor dilution linearity.The customer obtained the following results: 2-fold dilution was 5.902 ng/ml, 5-fold dilution was 2.739 ng/ml, and 10-fold dilution was 1.608 ng/ml.Patient history and historical results: 72-year-old male with a history of prostate cancer with a prostatectomy on (b)(6) 2023.(b)(6) 2023.Psa result was 6.1 ng/ml and testosterone was 0.03 ng/ml.(b)(6) 2023.Psa result was 6.3 ng/ml.(b)(6) 2023.Psa result was 6.7 ng/ml.(b)(6) 2023.Patient had total prostatectomy.(b)(6) 2023.Psa result was 8.66 ng/ml.(b)(6) 2022 psa result was 8.36 ng/ml.December 2019 psa result was 8.66 ng/ml there was no reported impact to patient management.

• Brand Name: ARCHITECT TOTAL PSA
• Type of Device: TOTAL, PROSTATE SPECIFIC AG (NONCOMPLEXED/COMPLEXED) FOR DET OF PROSTATE CANCER
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION; finisklin business park; sligo F91VY 44; EI F91VY44
• Manufacturer (Section G): ABBOTT IRELAND DIAGNOSTICS DIVISION; 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: 17873964
• MDR Text Key: 325846471
• Report Number: 3008344661-2023-00174
• Device Sequence Number: 1
• Product Code: MTF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P910007
• 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
• Report Date: 10/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2024
• Device Catalogue Number: 07K70-27
• Device Lot Number: 49488FN00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2023
• 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, ISR60422.