MAUDE Adverse Event Report: ABBOTT IRELAND ARCHITECT TOTAL PSA

Catalog Number 07K70-30

Device Problems Nonstandard Device (1420); Low Test Results (2458)

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

Event Date 06/06/2016

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.(b)(4).This report is being filed on an international product, list number 07k70, that has a similar product distributed in the us, list number 06c06.

Event Description

The customer reports that one sample generated an initial architect total psa assay result of 0.00 ng/ml on architect i2000sr analyzer serial number (b)(4).The sample retested at 5.79 ng/ml on architect i2000sr analyzer serial number (b)(4).The following day the sample was retested on this same analyzer and generated a result of 5.84 ng/ml.No suspect results were reported out of the lab with no reported patient impact.

Manufacturer Narrative

No return sample was available for analysis and no testing of retained kits was required as review of the customer data confirmed the expected results were consistently obtained on retest of the sample, suggesting a possible sample integrity issue for the single false depressed result obtained.A review of the manufacturing documentation did not identify any issues associated with the customer observation.A review of complaint tracking and trending metrics was performed and identified no adverse trends in conjunction with the complaint issue currently under evaluation.The architect total psa assay package insert contains information to address the current customer issue.Based on the available information from the customer site and from the results of this evaluation, there is no evidence to reasonably suggest a product malfunction occurred.The issue is related to one discreet patient sample.No additional issues were identified.

Manufacturer Narrative

The device evaluation was reassessed and concluded that a malfunction occurred; therefore, the device was not performing as intended.

• 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: 5748750
• MDR Text Key: 48922660
• Report Number: 3008344661-2016-00046
• Device Sequence Number: 1
• Product Code: LTJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 05/15/2017

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: 11/16/2016
• Device Catalogue Number: 07K70-30
• Device Lot Number: 60322FN00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/06/2016
• Initial Date FDA Received: 06/24/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 07/05/2016; 05/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2016
• 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