MAUDE Adverse Event Report: ABBOTT IRELAND ARCHITECT TOTAL PSA

Catalog Number 07K70-30

Device Problem Low Test Results (2458)

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

Event Date 01/25/2019

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.There is no further patient information provided due to privacy issues.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 results provided were: on (b)(6) 2019 = 0.945ng/ml / new sample (b)(6) 2019 = 22.5ng/ml / measured at another hospital = approximately 30ng/ml (unknown method).There was no reported impact to patient management.

Manufacturer Narrative

A review of tickets determined this is the only complaint received to date for this issue on lot 90197fn00 and no trends were identified.Return testing was not completed as returns were not available.A review of instrument log data for architect serial number (b)(4), confirmed daily and weekly maintenance was completed on both the 25jan2019 and the 21feb2019.Historical performance of the architect total psa lot 90197fn00 was evaluated using world wide data from abbottlink.The median population result for lot 90197fn00 falls within 1sd of the established baseline, confirming no systemic issue for the product.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation no product deficiency was identified for the architect total pda, lot 90197fn00.

• 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: 8438420
• MDR Text Key: 139605336
• Report Number: 3008344661-2019-00037
• 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: 04/22/2019

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 Expiration Date: 07/19/2019
• Device Catalogue Number: 07K70-30
• Device Lot Number: 90197FN00
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/25/2019
• Initial Date FDA Received: 03/20/2019
• Supplement Dates Manufacturer Received: 04/02/2019
• Supplement Dates FDA Received: 04/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR ANALYZER, LIST # 03M74-01,; ARCHITECT I2000SR ANALYZER, LIST # 03M74-01,; SERIAL # ISR60046; SERIAL # ISR60046