MAUDE Adverse Event Report: ABBOTT IRELAND ARCHITECT TOTAL PSA

Catalog Number 07K70-27

Device Problem High Test Results (2457)

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

Event Date 08/29/2016

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 7k70 that has a similar product distributed in the us, list number 6c06.

Event Description

The customer stated that the architect analyzer has generated falsely elevated total psa results on one patient.The results provided were: (b)(6) 2016 = 11.7 / (b)(6) 2016 = 2.5ng/ml / previous results at a different clinic were - (b)(6) 2014 = 20.1 / (b)(6) 2014 = 0.8.There was no reported impact to patient management.

Manufacturer Narrative

An evaluation was performed by reviewing the complaint text, reviewing other customer complaints for similar issues, accuracy testing, a review of labeling, and a review of historical records.The customer observed a potentially falsely elevated total psa result while using architect total psa reagent 7k70-25 lot 61499fn00.A review of complaints determined that there are no other complaints for this lot and no trends for the product.There was no patient sample available to assist in the investigation.Accuracy testing of a serum based panel was performed using a retained kit of lot 61499fn00.All specifications were met indicating that lot 61499fn00 is performing acceptably.A review of the manufacturing records did not identify any issues associated with the customer observation during the manufacturing of this lot.A review of labeling shows that there is adequate information provided to address the customer's issue of falsely elevated total psa results.Based on all available information and this investigation, the architect total psa reagent 7k70-25, lot 61499fn00, performed as intended and no product deficiency was identified.

Manufacturer Narrative

The device evaluation was reassessed and concluded that a malfunction occurred, therefore the device was not performing as intended.

• Brand Name: ARCHITECT TOTAL PSA
• Type of Device: TOTAL PSA
• Manufacturer (Section D): ABBOTT IRELAND; diagnostics division; finisklin business park; sligo NA ; EI NA
• Manufacturer (Section G): ABBOTT IRELAND; diagnostics division; finisklin business park; sligo NA ; EI NA
• Manufacturer Contact: noemi romero-kondos, rn bsn ; 100 abbott park road; dept. 09b9, lccp1-3; abbott park, IL 60064-3537 ; 224667-512
• MDR Report Key: 6030895
• MDR Text Key: 57490437
• Report Number: 3008344661-2016-00066
• Device Sequence Number: 1
• Product Code: MTF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P910007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/19/2017
• Device Catalogue Number: 07K70-27
• Device Lot Number: 61499FN00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: SERIAL # (B)(4)
• Patient Age: 63 YR