MAUDE Adverse Event Report: ABBOTT IRELAND ARCHITECT TOTAL PSA; TOTAL, PROSTATE SPECIFIC AG (NONCOMPLEXED/COMPLEXED) FOR DET OF PROSTATE CANCER

Catalog Number 07K70-30

Device Problem Low Test Results (2458)

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

Event Date 12/18/2020

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.This report is being filed on an international product, list number 7k70 that has a similar product distributed in the us, list number 6c06.

Event Description

The customer generated discrepant results for one patient while using the architect total psa (prostate specific antigen) and architect free psa (prostate specific antigen) assays.The following data was provided: sid (b)(6), tpsa 0.568 ng/ml, fpsa 1.613 ng/ml.Retest results were noted as being consistent with initial results.Per clinical feedback the results are inverted.No impact to patient management was reported.

Manufacturer Narrative

H6 health effect impact code: f26.Component code: g01003.D8 was this device serviced by a third party? no.A review of tickets was performed for reagent lot number 20272fn00.The ticket search determined that there is normal complaint activity for the reagent lot.A review of tracking and trending did not identify any trends for the complaint issue.Return testing was not completed as returns were not available.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.A review of labeling concluded that the issue is sufficiently addressed.Based on the investigation no systemic issue or deficiency of the architect total psa lot 20272fn00 was identified.

Manufacturer Narrative

This follow up is submitted to populate fields d8 and/or h6 with data that had previously been provided in field.H10.There is no change to the content of the data.

• Brand Name: ARCHITECT TOTAL PSA
• Type of Device: TOTAL, PROSTATE SPECIFIC AG (NONCOMPLEXED/COMPLEXED) FOR DET OF PROSTATE CANCER
• Manufacturer (Section D): ABBOTT IRELAND; finisklin business park; sligo F91VY 44; EI F91VY44
• MDR Report Key: 11144968
• MDR Text Key: 226321331
• Report Number: 3008344661-2021-00006
• 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,Followup
• Report Date: 06/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/25/2021
• Device Catalogue Number: 07K70-30
• Device Lot Number: 20272FN00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC FREE PSA RGT (400T), 07K71-20, 16071FN00; ARC FREE PSA RGT (400T), 07K71-20, 16071FN00; ARC FREE PSA RGT (400T), 07K71-20, 16071FN00; ARC I2000SR INST, 03M74-02, ISR61338; ARC I2000SR INST, 03M74-02, ISR61338; ARC I2000SR INST, 03M74-02, ISR61338