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

Catalog Number 07K70-25

Device Problem Low Test Results (2458)

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

Event Date 09/23/2020

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.This report is being filed on an international product, list number 7k70 that has a similar product distributed in the us, list number 6c06.Patient identifier sid: (b)(6).

Event Description

The customer reported falsely decreased architect total psa results on four patients.Results provided: (b)(6) 2020: sid: (b)(6) = 13.4443 / 6.655 / 6.95 ng/ml; sid: (b)(6) = 4.09 / 2.279 ng/ml; sid: (b)(6)= 5.432 / 2.717 ng/ml; sid: (b)(6) = 4.963 / 2.713 ng/ml.No impact to patient management was reported.

Manufacturer Narrative

A review of complaints for the architect total psa, lot# 11451fn00 assay determined that there are no trends for the product related to patient results.Return testing was not completed as returns were not available.Global data was evaluated and the patient median result for lot 11451fn00 was analyzed and found to be within established baselines and confirms no systemic issues for this lot.A review of the manufacturing documentation did not identify any issues associated with the customer¿s observation.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 total psa, lot# 11451fn00 assay.

• Brand Name: ARCHITECT TOTAL PSA
• Type of Device: TOTAL, PROSTATE SPECIFIC AG (NONCOMPLEXED/COMPLEXED) FOR DET OF PROSTATE CANCER
• Manufacturer (Section D): ABBOTT IRELAND; finisklin business park; sligo F91VY 44; EI F91VY44
• MDR Report Key: 10677985
• MDR Text Key: 211362824
• Report Number: 3008344661-2020-00077
• Device Sequence Number: 1
• Product Code: MTF
• Combination Product (y/n): N
• PMA/PMN Number: P910007
• 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: 11/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/10/2021
• Device Catalogue Number: 07K70-25
• Device Lot Number: 11451FN00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2K PROC MOD, 03M74-01, ISR06939; ARC I2K PROC MOD, 03M74-01, ISR06939; ARC I2K PROC MOD, 03M74-01, ISR06939