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

Catalog Number 07K71-20

Device Problem Low Test Results (2458)

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

Event Date 05/13/2021

Event Type  malfunction  

Manufacturer Narrative

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 7k71 that has a similar product distributed in the us, list number 6c07.

Event Description

The customer reported a falsely decreased architect free psa result on a patient.Results provided: sid (b)(6) = 0.216/1.106 (no uom provided).No impact to patient management was reported.

Manufacturer Narrative

D4 lot no updated from unknown to 13217fn00.

Manufacturer Narrative

A review of complaints for the architect free psa, lot# 13217fn00 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 13217fn00 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.It is noted that the date of patient testing was may2021 and the reagent lot that was used, 13217fn00, expired on 26feb2021.Per product labeling, the reagent kits should be only used until the expiration date.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation no systemic issue or product deficiency was identified for the architect free psa, lot# 13217fn00 assay.

• Brand Name: ARCHITECT FREE PSA REAGENT KIT
• 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: 11995415
• MDR Text Key: 256282294
• Report Number: 3008344661-2021-00118
• Device Sequence Number: 1
• Product Code: MTG
• Combination Product (y/n): N
• PMA/PMN Number: P980007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/26/2021
• Device Catalogue Number: 07K71-20
• Device Lot Number: 13217FN00
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/01/2021
• Initial Date FDA Received: 06/14/2021
• Supplement Dates Manufacturer Received: 06/15/2021; 07/14/2021
• Supplement Dates FDA Received: 07/06/2021; 07/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2SR REFURB-SEKAT, 03M74-97, ISR05150; ARC I2SR REFURB-SEKAT, 03M74-97, ISR05150; ARC I2SR REFURB-SEKAT, 03M74-97, ISR05150