MAUDE Adverse Event Report: ABBOTT IRELAND ARCHITECT TOTAL PSA

Catalog Number 07K70-27

Device Problem High Test Results (2457)

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

Event Type  malfunction  

Manufacturer Narrative

All patient details have been included.No additional patient information is available.This report is being filed on an international product, architect total psa, list 7k70, that has a similar product distributed in the us, total psa, list number 6c06.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer reported false elevated total psa data for a male patient undergoing treatment for cholestasis due to hepatic dysfunction, when processing on the architect i2000sr.The following data was provided: (b)(6) 2019: initial result was >100 and after x20 dilution the result was >2000 ng/ml.(b)(6) 2019: the result was >2000 ng/ml upon x20 dilution.The customer stated they were expecting a result in the normal range as there was no abnormality observed on prostate examination.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 the performance of the assay, a review of product quality history, and a review of product labeling.The ticket searches determined normal complaint activity for lot 01370fn00.Complaint trending report review did not identify any trends.Worldwide field data was used to assess the performance of the architect total psa assay and did not identify any systemic issues.A review of the product quality history did not identify issues associated with the customer observation.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; sligo NA ; EI NA
• MDR Report Key: 9100152
• MDR Text Key: 159822527
• Report Number: 3008344661-2019-00115
• 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: 11/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/09/2020
• Device Catalogue Number: 07K70-27
• Device Lot Number: 01370FN00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR ANALYZER; LIST 03M74-01, SERIAL (B)(4)