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 Date 05/12/2018

Event Type  malfunction  

Manufacturer Narrative

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.Patient information: no specific patient information was provided.

Event Description

The customer reported falsely elevated architect total psa results for a patient undergoing treatment for prostate cancer.The customer provided the following results and indicated the results generated in may and september were falsely elevated.On (b)(6) 2018: 0.193.On (b)(6) 2018: 5.505.On (b)(6) 2018: 26.800.On (b)(6) 2018: 13.058.On (b)(6) 2018: 5.663.No adverse impact to patient management was reported.

Manufacturer Narrative

Review of complaint activity did not identify any adverse or non-statistical trends for the architect total psa assay.Using worldwide field data the historical performance of the assay was reviewed.The patient median result for each reagent lot was analyzed and found to be within 2 standard deviations of the established baseline, confirming no systemic issue for the assay.Manufacturing documentation for the assay did not identify any issues associated with the complaint issue.Additionally, labeling was reviewed and sufficiently addresses the customer's issue.Based on the available information, no systemic issue or deficiency of the architect total psa assay was 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: 8430355
• MDR Text Key: 142634690
• Report Number: 3008344661-2019-00031
• 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: 04/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07K70-27
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/25/2019
• Initial Date FDA Received: 03/18/2019
• Supplement Dates Manufacturer Received: 04/05/2019
• Supplement Dates FDA Received: 04/18/2019
• 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 ISR60586; SERIAL ISR60586