MAUDE Adverse Event Report: ABBOTT IRELAND ALINITY I TOTAL PSA

Catalog Number 07P92-30

Device Problem Low Test Results (2458)

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

Event Date 06/26/2019

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Patient information: identifier: sid (b)(6) (male (b)(6)) and patient #2 (male (b)(6)); there was no additional patient information provided.This report is being filed on an international product, list number 7p92 that has a similar product distributed in the us, list number 6c06.

Event Description

The customer reported a falsely decreased alinity total psa result on two patients.Results provided: sid (b)(6) (male (b)(6)) (b)(6) 2019 = <0.01 / 0.324 / 0.335 / 0.336 ng/ml; patient#2 (male (b)(6)) (b)(6) 2019 = 0.048 / 0.150 ng/ml.No impact to patient management was reported.

Manufacturer Narrative

A review of complaints for the alinity i total psa (list 7p92), lot# 96041fn00 assay determined that there are no trends for the product related to patient results.Return testing was not completed as returns were not available.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 alinity i total psa (list 7p92), lot# 96041fn00 assay.

• Brand Name: ALINITY I TOTAL PSA
• Type of Device: TOTAL PSA
• Manufacturer (Section D): ABBOTT IRELAND; diagnostics division; finisklin business park; sligo NA ; EI NA
• MDR Report Key: 8790556
• MDR Text Key: 159328461
• Report Number: 3008344661-2019-00083
• Device Sequence Number: 1
• Product Code: MTF
• Combination Product (y/n): N
• 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: 10/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/09/2019
• Device Catalogue Number: 07P92-30
• Device Lot Number: 96041FN00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALINITY I PROCESSING MODULE LIST 03R65-01; ALINITY I PROCESSING MODULE LIST 03R65-01; SERIAL (B)(4).; SERIAL (B)(4).