MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ARCHITECT TOTAL PSA

Catalog Number 07K70-35

Device Problem High Test Results (2457)

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

Event Date 01/23/2020

Event Type  malfunction  

Manufacturer Narrative

All available patient information has been included, and no additional patient details are available.An evaluation is in process.A follow-up report will be submitted when the evaluation is completed.This report is being filed on an international product, list number 07k70 that has a similar product distributed in the us, list number 6c06.

Event Description

The customer reported a false elevated total prostate specific antigen (psa) for a (b)(6) year old male patient with prostate cancer, when processing on the architect i2000sr.Sid (b)(6) generated a result of 22 ng/ml.Previous result for this patient was 2 ng/ml range.Results of the dilution were provided: 1:1 = 22.02 ng/ml.1:2 = 33.89 ng/ml.1:5 = 51.92 ng/ml.1:10 = 64.40 ng/ml.The patient medical history includes hormone therapy and diabetes.No impact to patient management was reported.

Manufacturer Narrative

An investigation was performed for the customer issue and included a review of the complaint text, a search for similar complaints, a review of trending data, a review of historical data, and a review of product labeling.The ticket searches determined normal complaint activity for lot 06536fn00.The trending report review did not identify any trends for the product for the complaint issue.A review of historical data did not identify any issues.Additionally, it was determined that the patient median result for lot 06536fn00 is comparable to other lots in the field and falls within established baselines, confirming no systemic issue for the lot.Labeling was reviewed and found to be adequate.Based on all available information and abbott diagnostics' complaint investigation a product deficiency was not identified.

• Brand Name: ARCHITECT TOTAL PSA
• Type of Device: TOTAL PSA
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION; finisklin business park; diagnostics division; sligo NA ; EI NA
• MDR Report Key: 9688038
• MDR Text Key: 220247458
• Report Number: 3008344661-2020-00013
• Device Sequence Number: 1
• Product Code: MTF
• Combination Product (y/n): N
• PMA/PMN Number: P910007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 03/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/02/2020
• Device Catalogue Number: 07K70-35
• Device Lot Number: 06536FN00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR, LIST 03M74-01; ARCHITECT I2000SR, LIST 03M74-01; SERIAL (B)(4) ; SERIAL (B)(4)
• Patient Age: 70 YR