MAUDE Adverse Event Report: ABBOTT IRELAND ARCHITECT TOTAL PSA

Catalog Number 07K70-25

Device Problem High Test Results (2457)

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

Event Date 11/08/2016

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.(b)(6).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 elevated total psa results on three patient samples.The results provided were on (b)(6) 2016, sid (b)(6): initial = 20.853 / repeat = 0.356ng/ml; sid (b)(6) = 3.245 / 0.046ng/ml; sid (b)(6) = 1.202 / 0.027ng/ml.There was no reported impact to patient management.There was no additional patient information provided.

Manufacturer Narrative

The customer observed potentially falsely elevated total psa results for 3 patients while using architect total psa reagent 7k70-25 lot 67122fn01.A review of complaints determined there are no trends for falsely elevated results for the product.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 67122fn01.All specifications were met indicating that lot 67122fn01 is performing acceptably.A review of the manufacturing documentation of lot 67122fn01 did not identify any issues associated with the customer observation.A review of the product labeling concluded that the issue is sufficiently addressed.Based on this investigation the architect total psa, list number 7k70-25, lot 67122fn01, 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: 6147508
• MDR Text Key: 61543997
• Report Number: 3008344661-2016-00075
• 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,Followup
• Report Date: 05/16/2017

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: 08/23/2017
• Device Catalogue Number: 07K70-25
• Device Lot Number: 67122FN01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2016
• Initial Date FDA Received: 12/06/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/21/2016; 05/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2016
• 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: ARCHITECT I1000SR ANALYZER, LIST # 01L86-01,; SERIAL # (B)(4)