MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ARCHITECT TOTAL PSA

Catalog Number 07K70-35

Device Problem Low Test Results (2458)

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

Event Date 08/19/2020

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.There was no further patient information provided by the customer.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 reported falsely depressed architect total psa results on one patient.The following data was provided: sid (b)(6) generated a result of < 0.01 ug/l.Two weeks earlier the same patient sid (b)(6) generated a result of 1.085 ug/l.No impact to patient management was reported.

Manufacturer Narrative

After further evaluation, the suspect medical device was changed from architect total psa list 7k70-35, manufacturing site abbott ireland diagnostics division, sligo to the architect i2000sr instrument list 03m74-02 manufacturing site abbott laboratories irving, texas.Mdr number 3016438761-2020-00253-00 has been submitted and all further information will be documented under that mdr number.

• Brand Name: ARCHITECT TOTAL PSA
• Type of Device: TOTAL PSA
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION; finisklin business park; diagnostics division; sligo F91VY 44; EI F91VY44
• MDR Report Key: 10513454
• MDR Text Key: 238579693
• Report Number: 3008344661-2020-00068
• 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: 10/22/2020

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: 07K70-35
• Device Lot Number: 09517FN00
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/21/2020
• Initial Date FDA Received: 09/10/2020
• Supplement Dates Manufacturer Received: 10/15/2020
• Supplement Dates FDA Received: 10/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2000SR INST, 03M74-02, (B)(6) ; ARCHITECT I2000SR ANALYZER, LIST 03M74-02,; SERIAL (B)(6)