MAUDE Adverse Event Report: ABBOTT IRELAND 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 Known Impact Or Consequence To Patient (2692)

Event Date 10/29/2020

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.There was no additional patient information provided due to privacy issues.

Event Description

The customer reported falsely elevated architect total psa results on one known prostate cancer patient.The results provided were in (b)(6) 2018 = 16, hormone therapy started in (b)(6) 2020 with the following results: (b)(6) =0.96; (b)(6) =0.195; (b)(6) = 0.168, (b)(6) = 6.There was no reported impact to patient management.

Manufacturer Narrative

The complaint investigation for potential false elevated total psa results included a search for similar complaints, 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 13678fn00 was evaluated using worldwide data from abbottlink.The patient data was analyzed and compared to an established control limit.This evaluation indicated that the patient median result for lot 13678fn00 is within the established control limits, therefore, no unusual reagent lot performance was identified.Lot and trending review did not identify an increase in complaint activity for 13678fn00 for the issue and no related trend for the issue for the product.Device history record review of lot 13678fn00 did not show any potential non-conformances, or deviations.Labelling was reviewed and found to adequately address the issue.Per product labelling 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.Based on the investigation, no systemic issue or deficiency of the architect total psa assay, lot number 13678fn00 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: 10877357
• MDR Text Key: 239589219
• Report Number: 3008344661-2020-00126
• 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: 02/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/11/2021
• Device Catalogue Number: 07K70-27
• Device Lot Number: 13678FN00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2K PROC MOD, 03M74-01, ISR05473; ARC I2K PROC MOD, 03M74-01, ISR05473