MAUDE Adverse Event Report: ABBOTT IRELAND ARCHITECT TOTAL PSA

Catalog Number 07K70-25

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/23/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow-up report will be submitted once 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.Complete information for a.Patient information, 1.Patient identifier is (b)(4).

Event Description

The customer stated that the architect analyzer generated a falsely elevated total psa result on one patient sample.The results provided were: (b)(4) on (b)(6) 2015 = 5.028(4.0ng/ml = cutoff) / repeated sample on (b)(6)= 2.242ng/ml; sample repeated third time gave similar result as second test.There was no reported impact to patient management.There was no additional patient information provided.

Manufacturer Narrative

An evaluation was performed by reviewing the complaint text, other customer complaints for similar issues, accuracy testing, and review of labeling.A review of complaints determined that there is normal complaint activity and no trends for lot 54704lf00.No patient sample was available to assist in the investigation.Accuracy testing of a serum based panel sample, which mimics a patient sample, was performed using a retained kit of lot 54704lf00.All specifications were met indicating that lot 54704lf00 is performing acceptably.A review of the manufacturing documentation did not identify any issues associated with the customer observation.A review of the product labeling concluded that the complaint issue is sufficiently addressed.Based on all available information and this investigation, the architect total psa, list number (b)(4), lot number 54704lf00, performed as intended and no product deficiency was identified.

• 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: 5293123
• MDR Text Key: 33949014
• Report Number: 3008344661-2015-00031
• Device Sequence Number: 1
• Product Code: LTJ
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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
• Report Date: 12/30/2015

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: 06/03/2016
• Device Catalogue Number: 07K70-25
• Device Lot Number: 54704LF00
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/24/2015
• Initial Date FDA Received: 12/14/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/17/2015
• 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