MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ALINITY I TOTAL PSA REAGENT KIT; PROSTATIC SPECIFIC ANTIGEN (PSA)

Catalog Number 07P92-30

Device Problem High Test Results (2457)

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

Event Date 12/03/2019

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.There is no further patient information provided due to privacy issues.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 falsely elevated alinity i total psa results on one patient.The results provided were: on (b)(6) 2019 sid (b)(4) = 4.96ug/l (diagnostic range 0.0 - 3.9ug/l).The patient is being monitored post prostate cancer treatment and his previous results were less than 0.01ug/l.Repeat sample on (b)(6) 2020 = less than 0.01ug/l.There was no reported impact to patient management.

Manufacturer Narrative

A review of complaint tickets for the assay nor testing could be completed as the lot is unknown.A review of complaints determined there are no trends for the product for the complaint issue.Return testing was not completed as returns were not available.A review of the manufacturing documentation did not identify any issues associated with the customer's 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 assay.

Manufacturer Narrative

Suspect medical device, 4.Catalog# from 07p92-31 to 07p92-30; udi from (b)(4) to (b)(4).

• Brand Name: ALINITY I TOTAL PSA REAGENT KIT
• Type of Device: PROSTATIC SPECIFIC ANTIGEN (PSA)
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION; finisklin business park; diagnostics division; sligo NA ; EI NA
• MDR Report Key: 9695211
• MDR Text Key: 198530929
• Report Number: 3008344661-2020-00014
• Device Sequence Number: 1
• Product Code: MTF
• UDI-Device Identifier: 00380740158323
• UDI-Public: 00380740158323
• 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,Followup
• Report Date: 03/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07P92-30
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALINITY I PROCESSING MODULE, LN 03R65-01,; ALINITY I PROCESSING MODULE, LN 03R65-01,; ALINITY I PROCESSING MODULE, LN 03R65-01,; SERIAL # (B)(6) ; SERIAL # (B)(6) ; SERIAL # AI01139
• Patient Age: 65 YR