MAUDE Adverse Event Report: ABBOTT IRELAND ARCHITECT TOTAL PSA

Catalog Number 07K70-30

Device Problem Low Test Results (2458)

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

Event Date 11/28/2016

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 generated falsely decreased total psa results on one patient.The results provided were: (b)(6) 2016 = 4.09 ng/ml / repeated same day = 0.867 / on (b)(6) 2016 two additional tubes from the same patient = 3.706 / 3.582 ng/ml.There was no reported impact to patient management.There was no additional patient information provided.

Manufacturer Narrative

The customer reported a single depressed total psa result for one patient when tested using architect total psa, list 7k70-30, lot 66173fn00.A review of tickets determined that there is no unusual activity for lot 66173fn00 and no trends for this issue.No patient sample was available to assist in the investigation.Accuracy testing of a serum based panel, which mimics a patient sample and with a target concentration of 3.86 ng/ml, was performed using a retained kit of lot 66173fn00.All specifications were met indicating that lot 66173fn00 is performing acceptably.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.A review of product labeling shows adequate information to troubleshoot the falsely decreased patient result.Based on all available information and this investigation, the assay 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: 6192967
• MDR Text Key: 62964316
• Report Number: 3008344661-2016-00077
• Device Sequence Number: 1
• Product Code: LTJ
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 05/26/2017

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: 07/27/2017
• Device Catalogue Number: 07K70-30
• Device Lot Number: 66173FN00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2016
• Initial Date FDA Received: 12/21/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/31/2017; 05/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2016
• 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)