MAUDE Adverse Event Report: ABBOTT IRELAND ARCHITECT TOTAL PSA

Catalog Number 07K70-25

Device Problem Incorrect Measurement (1383)

Patient Problem No Consequences Or Impact To Patient (2199)

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 07k70, that has a similar product distributed in the us, list number 06c06.(b)(4).

Event Description

The customer reports that a male patient sample generated an initial architect total psa assay result of 2.36 ng/ml.The sample retested at 4.28 and 4.08 ng/ml.No suspect results were reported from the lab with no patient impact.

Manufacturer Narrative

No returns were available from the customer site for this evaluation.A review of complaint tracking and trending metrics was performed and identified no adverse trends in conjunction with the complaint issue currently under evaluation.Accuracy testing was performed using in-house retained reagent of lot 54704lf00.All specifications were met, demonstrating the acceptable performance of this lot of the architect total psa reagent.The architect total psa assay package insert contains information to address the current customer issue.Based on the available information from the customer site and from the results of this evaluation, there is no evidence to reasonably suggest a product malfunction occurred.Replacing the sample probe resolved the customer's concern.The issue was addressed through standard troubleshooting procedures.

• 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: 5258812
• MDR Text Key: 32501355
• Report Number: 3008344661-2015-00028
• 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: 12/07/2015

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/09/2015
• Initial Date FDA Received: 12/01/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/07/2015
• 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