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

Catalog Number 07K70-25

Device Problem Low Test Results (2458)

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

Event Date 12/30/2019

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 results provide were: on (b)(6) 2019 sid (b)(6) initial = >100.00ng/ ml / retest = 0.799ng/ml / >100.000 / neat = 394.083 / diluted 1:4 = 98.996x4 = 395.984 / on (b)(6) 2019 retest neat = 378.445ng/ml.There was no reported impact to patient management.

Manufacturer Narrative

A review of tickets found only one additional complaint for lot 03330fn00 and no trends for the product for the complaint issue.Return testing was not completed as returns were not available.Historical performance of reagent lot 03330fn00 was evaluated using world wide data from abbottlink.The data determined that the patient median result for lot 03330fn00 is comparable to other lots in the field and confirms no systemic issue.This complaint ticket references service ticket (b)(4), initiated for erratic results obtained on the customers instrument.Through the service ticket, review of the instrument indicated the ph of the internal buffer solution was approximately ph8.The abbott customer service representative recommended replacement of the buffer solution and instrument flush after which the ph was determined to be approximately 7, suggesting contamination of the on-board buffer.The current complaint ticket documents that after the change of buffer solution, no further problems were identified.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 psa reagent, lot 03330fn00.

• Brand Name: ARCHITECT TOTAL PSA
• Type of Device: TOTAL PSA
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION; finisklin business park; diagnostics division; sligo NA ; EI NA
• MDR Report Key: 9607283
• MDR Text Key: 220245684
• Report Number: 3008344661-2020-00004
• 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: 02/25/2020

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 Expiration Date: 04/18/2020
• Device Catalogue Number: 07K70-25
• Device Lot Number: 03330FN00
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/31/2019
• Initial Date FDA Received: 01/20/2020
• Supplement Dates Manufacturer Received: 02/25/2020
• Supplement Dates FDA Received: 02/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I1000SR ANALYZER, LN 01L86-01,; ARCHITECT I1000SR ANALYZER, LN 01L86-01,; SERIAL # (B)(4) ; SERIAL # (B)(4)
• Patient Age: 84 YR