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

Catalog Number 07K70-35

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/21/2020

Event Type  malfunction  

Manufacturer Narrative

Patient identifier: sid (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.This report is being filed on an international product, list number 7k70 that has a similar product distributed in the us, list number 6c06.

Event Description

The customer reported false elevated architect total psa results on a (b)(6) year-old white male patient.The results provided were: on (b)(6) 2020 sid (b)(6) initial = 5.18 ng/ml, repeated 2.67 ng/ml.No impact to patient management was reported.

Manufacturer Narrative

The complaint investigation included a search for similar complaints, and review of complaint text, trending data, labelling, and device history records review.Return testing was not completed as returns were not available.Performance of reagent lot 09517fn00 was evaluated using world wide data and indicated that the patient median result for lot 09517fn00 is within the established control limit and suggested that the performance of the lot is acceptable.Review of tracking and trending reports did not identify any related trends for the issue for the product.Device history record review did not identify any issues with the likely cause lot 09517fn00 and complaint issue.A review of labeling concluded that the issue is sufficiently addressed.Per the limitations of the assay section within the product package insert, serum psa concentrations should not be interpreted as absolute evidence for the presence or absence of prostate cancer.The psa value should be used in conjunction with information available from clinical evaluation and other diagnostic procedures such as dre.In this case, retest of the sample returned the expected lower total psa results.Based on the investigation, no systemic issue or deficiency of the architect total psa assay, lot number 09517fn00 was identified.

• 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: 10659197
• MDR Text Key: 239825537
• Report Number: 3008344661-2020-00075
• 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: 11/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/06/2020
• Device Catalogue Number: 07K70-35
• Device Lot Number: 09517FN00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2K PROC MOD, 03M74-01, ISR08468; ARC I2K PROC MOD, 03M74-01, ISR08468
• Patient Age: 64 YR