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 Type  malfunction  

Manufacturer Narrative

(b)(6).This report is being filed on an international product, list 7k70 that has a similar product distributed in the u.S., list 6c06.An evaluation is in process.A followup report will be submitted when the evaluation is complete.

Event Description

The account generated false elevated architect total psa of 76.03 ng/ml on id (b)(6) that did not match clinical diagnosis.Historically, the patient tested architect psa of 9.4 ng/ml on (b)(6) 2016 and had a negative needle biopsy and psa of 14.9 ng/ml in october 2015.No impact to patient management was reported.

Manufacturer Narrative

The ticket searches determined that there is no unusual activity for the likely cause lot for this issue and the complaint trending report review determined that there is no non statistical or adverse trend for the issue for the product.No patient sample was available for evaluation.Therefore, testing of a serum based panel sample which mimics a patient sample was performed.All specifications were met indicating the complaint lot 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 issue is sufficiently addressed.Based on all available information and evaluation, 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 at the customer site.However, no systemic issue and/or product deficiency was identified.The conclusion code in evaluation codes was changed from (b)(4).

• 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: 5893684
• MDR Text Key: 52669730
• Report Number: 3008344661-2016-00056
• Device Sequence Number: 1
• Product Code: LTJ
• 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: 06/08/2017

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: 02/12/2017
• Device Catalogue Number: 07K70-25
• Device Lot Number: 62130FN00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/26/2016
• Initial Date FDA Received: 08/22/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 10/07/2016; 06/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2016
• 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
• Patient Age: 67 YR