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 03/14/2018

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.No additional patient information was obtained by the customer.

Event Description

The customer reported falsely decreased total psa results on one patient.The results provided were: sid (b)(6) initial result on the (b)(4) = 0.028ug/l / repeat = 13.0ug/l / third test on i1000 = 12.7ug/l.There was no reported impact to patient management.

Manufacturer Narrative

Correction to suspect medical device; 4.Lot # from unknown to 80372fn00.The customer observed a single false depressed total psa result for a patient sample using architect total psa lot 80372fn00, on their architect i2000sr, serial number (b)(4).A review of results for patient samples tested before and after the original depressed result was performed by abbott personnel who identified 2 tubes tested after the suspect result was generated had associated error code 0302, which indicates a hardware failure or the user pressed stop.A review of the pressure, lls and result logs for the depressed result indicated no anomalies.The field service engineer reviewed the instrument for potential hardware issues with none identified.Additional inspection of the sample probe found noticeable build up, so the probe was cleaned and recalibrated.Return testing was not completed as returns were not available.A review of tickets determined that there is no increase in complaints for lot 80372fn00 and no trend for the product for this issue was identified.Historical performance of architect total psa, list number 7k70 was evaluated using world wide data from abbott link.The median population result for lot 80372fn00 falls within 1 standard deviation of the established center line, indicating the lot is performing acceptably.Manufacturing documentation for architect total psa, lot 80372fn00 was reviewed and no contributing factors to the complaint could be identified.A review of labeling concluded that the issue is sufficiently addressed and that insufficient processing of sample, or disruption of the sample during transportation may cause depressed results.Based on the investigation, no product deficiency was identified for the architect total psa, lot 80372fn00.

• Brand Name: ARCHITECT TOTAL PSA
• Type of Device: TOTAL PSA
• Manufacturer (Section D): ABBOTT IRELAND; diagnostics division; finisklin business park; sligo NA ; EI NA
• Manufacturer (Section G): ABBOTT IRELAND; diagnostics division; finisklin business park; sligo NA ; EI NA
• Manufacturer Contact: noemi romero-kondos, rn bsn ; 100 abbott park road; dept. 09b9, lccp1-3; abbott park, IL 60064-3537 ; 224667-512
• MDR Report Key: 7402785
• MDR Text Key: 105256850
• Report Number: 3008344661-2018-00025
• Device Sequence Number: 1
• Product Code: LTJ
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P910007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/20/2018
• Device Catalogue Number: 07K70-30
• Device Lot Number: 80372FN00
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1