MAUDE Adverse Event Report: ABBOTT IRELAND ARCHITECT TOTAL PSA

Catalog Number 07K70-25

Device Problem Low Test Results (2458)

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

Event Type  malfunction  

Manufacturer Narrative

All available patient information was included.Additional patient details are not available.An evaluation is in process.A final report will be submitted when the evaluation is complete.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 falsely depressed architect total psa result for an (b)(6) year old male patient.The customer indicated the patient was diagnosed, treated and monitored for prostate cancer at an alternate facility.The following results were provided: (b)(6) 2018: 0.01 at alternate facility (method unknown), (b)(6) 2019: 0.16 at alternate facility (method unknown), (b)(6) 2019: 5.14 at alternate facility (method unknown), (b)(6) 2019: architect 7.768 ng/ml, (b)(6) 2019: architect 7.605 ng/ml, (b)(6) 2019: architect 0.735 ng/ml and retest alternate analyzer 0.806 ng/ml.No impact to patient management was reported.

Manufacturer Narrative

Investigation of the customer's issue included a review of the complaint text, a search for similar complaints, review of field data, review of manufacturing records, and a review of labeling.Review of complaint activity did not identify any trends for the architect total psa assay.An increase in complaint activity was not identified for reagent lot 01370fn00.Using world wide field data the performance of reagent lot 01370fn00 was evaluated and compared to the performance of other on-market reagent lots in the field.This evaluation indicated that the patient median result for the lot was comparable to other architect total psa reagent lots.Manufacturing documentation for the likely cause lot 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: 8902185
• MDR Text Key: 160366089
• Report Number: 3008344661-2019-00102
• Device Sequence Number: 1
• Product Code: LTJ
• 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: 10/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/09/2020
• Device Catalogue Number: 07K70-25
• Device Lot Number: 01370FN00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR ANALYZER, LN 03M74-01; ARCHITECT I2000SR ANALYZER, LN 03M74-01; SERIAL # (B)(4); SERIAL (B)(4)
• Patient Age: 82 YR