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

Catalog Number 07K71-20

Device Problem High Test Results (2457)

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 7k71 that has a similar product distributed in the us, list number 6c07.

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 16071fn00.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.Performance testing was performed using an in-house retain kit of lot 16071fn00.All specifications were met indicating the lot is performing acceptably.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 free psa lot 16071fn00 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 FREE PSA REAGENT KIT
• 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: 11144981
• MDR Text Key: 226031526
• Report Number: 3008344661-2021-00007
• Device Sequence Number: 1
• Product Code: MTG
• Combination Product (y/n): N
• PMA/PMN Number: P980007
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/10/2021
• Device Catalogue Number: 07K71-20
• Device Lot Number: 16071FN00
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/18/2020
• Initial Date FDA Received: 01/11/2021
• Supplement Dates Manufacturer Received: 03/12/2021; 06/20/2021
• Supplement Dates FDA Received: 04/04/2021; 06/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2000SR INST, 03M74-02, (B)(6); ARC I2000SR INST, 03M74-02, (B)(6); ARC I2000SR INST, 03M74-02, (B)(6); ARC TOTAL PSA RGT(2000T, 07K70-30, 20272FN00; ARC TOTAL PSA RGT(2000T, 07K70-30, 20272FN00; ARC TOTAL PSA RGT(2000T, 07K70-30, 20272FN00; ARC I2000SR INST, 03M74-02, (B)(4); ARC TOTAL PSA RGT(2000T, 07K70-30, 20272FN00