MAUDE Adverse Event Report: ABBOTT IRELAND ARCHITECT TOTAL PSA

Catalog Number 07K70-25

Device Problem High Test Results (2457)

Patient Problem No Code Available (3191)

Event Date 05/03/2017

Event Type  malfunction  

Manufacturer Narrative

This report is being filed on an international product, architect total psa, list 7k70, that has a similar product distributed in the us, architect total psa, list number 6c06.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Event problem and evaluation codes: (b)(4).

Event Description

The customer reported a patient received a pet scan and radiation therapy due to an elevated architect total psa result.The patient was tested on (b)(6) 2015 on the architect total psa assay as a part of routine follow up for a prostate removal which occurred in 2014.The architect generated a prostate-specific antigen (psa) result of 0.3 ug/l (sample (b)(6)).The patient was referred to radiation oncology at a private hospital and a pet scan was performed on (b)(6) 2015 which was inconclusive.Due to the inconclusive imaging and the psa result, a course of radiotherapy was commenced at the private hospital on (b)(6) 2015.A baseline psa was taken at the private hospital on the first day of radiotherapy.At a follow up appointment with the radiation oncologist following approximately 5 treatments, the baseline psa result was noted to be <0.01 ug/l on the roche assay.On (b)(6) the psa was repeated on the roche assay generating a result of <0.01 ug/l and the unnecessary radiotherapy was discontinued.

Manufacturer Narrative

Further investigation of the customer issue included a review of the complaint text, review of investigation performed at the customer site, a search for similar complaints, and a review of labeling.Review of complaint activity did not identify any adverse or non-statistical trends for the architect total psa assay.Additionally, no unusual complaint activity was identified for reagent lot 47139lf00.Testing could not be performed as the likely cause reagent lot expired in november 2015.The customer provided a detailed summary of the review performed at their facility.This review documented that all assays were running as expected when the discordant result was generated and no concerns were noted for any other samples tested.Both internal and external quality assurance results for the psa assay showed acceptable performance.This review also included recommendation made by the medical review team which included that a patient should receive psa testing at the same laboratory using the same assay each time which did not happen in this case.It also documents that a false positive rate of 0.3% with psa testing after radical prostatectomy is recognized in literature.The european association of urology defines biochemical recurrence as two consecutive psa values of >0.2 ug/l and rising.In this incident, only one result was recorded on architect at 0.3 ug/l.Labeling was reviewed and sufficiently addressed the customer's issue.The architect total psa package insert states that the concentration of total psa in a given specimen, determined with assays from different manufacturers, can vary due to differences in assay methods and reagent specificity.The results reported by the laboratory to the physician must include the identity of the total psa assay used.Values obtained with different assay methods, including abbott psa assays, cannot be used interchangeably.If, in the course of monitoring a patient, the assay method used for determining total psa levels serially is changed, additional sequential testing should be carried out.Prior to changing assays, the laboratory must confirm baseline values for patients being serially monitored.Based on this investigation and the available information, no systemic issue or product deficiency of the architect total psa assay was identified.

• 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: 6954707
• MDR Text Key: 90551010
• Report Number: 3008344661-2017-00091
• 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: 10/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2015
• Device Catalogue Number: 07K70-25
• Device Lot Number: 47139LF00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/21/2014
• 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
• Patient Outcome(s): Other