MAUDE Adverse Event Report: ABBOTT IRELAND ARCHITECT TOTAL PSA

Catalog Number 07K70-35

Device Problem Low Test Results (2458)

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

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 (b)(4) that has a similar product distributed in the us, list number (b)(4).

Event Description

The customer reported a falsely decreased architect total psa result on one (b)(6) male patient previously diagnosed with prostate cancer.Results provided: 1.5 ng/ml, repeated the same.The patient is monitored every three months.Previous results provided: (b)(6) 2019 = 30.5 ng/ml; (b)(6) 2019 = 23.9 ng/ml; (b)(6) 2019 = 8.5 ng/ml.No impact to patient management was reported.

Manufacturer Narrative

A review of complaints for the architect total psa, lot# 01369fn00 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 01369fn00 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 customers 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# 01369fn00 assay.

• Brand Name: ARCHITECT TOTAL PSA
• Type of Device: TOTAL PSA
• Manufacturer (Section D): ABBOTT IRELAND; diagnostics division; finisklin business park; sligo NA ; EI NA
• MDR Report Key: 9191353
• MDR Text Key: 194480241
• Report Number: 3008344661-2019-00123
• 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: 11/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/09/2020
• Device Catalogue Number: 07K70-35
• Device Lot Number: 01369FN00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR ANALYZER LIST 03M74-01; ARCHITECT I2000SR ANALYZER LIST 03M74-01; SERIAL (B)(4); SERIAL (B)(4)