MAUDE Adverse Event Report: ABBOTT IRELAND ARCHITECT TOTAL PSA

Catalog Number 07K70-27

Device Problem High Test Results (2457)

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

Event Type  malfunction  

Manufacturer Narrative

Evaluation of the customer issue included a complaint text review, a search for similar complaints, device history review, labeling review, and field data review.Returns were not available.No adverse trend was identified for the customer issue.Device history review did not identify any issues that may have caused the customer issue.Labeling was reviewed and found to be adequate.Abbott link world wide data was used to evaluate historical product field performance.Patient data was analyzed and compared to an established control limit.The evaluation indicated that the patient median result for the complaint lot was comparable to other lots in the field between (b)(6) 2018 to (b)(6) 2018.No unusual reagent lot performance was identified.Based on all available information and abbott diagnostics evaluation, no systemic issue was identified and no product deficiency was found.This report is being filed on an international product, list number (b)(4) that has a similar product distributed in the us, list number (b)(4).

Event Description

The customer observed falsely elevated results with poor dilution linearity while using architect total psa (prostate specific antigen) reagents.The following data was provided for the same patient.Initial (undiluted) greater than 100 ng/ml, diluted (1:10) greater than 100 ng/ml, diluted (1:20) 26.8 ng/ml, diluted (1:100) 214.24 ng/ml.Per the product package insert, specimens with values exceeding 100 ng/ml are flagged with code greater than 100.000 and may be diluted.No impact to patient management was reported.

• 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: 7986516
• MDR Text Key: 126107398
• Report Number: 3008344661-2018-00089
• Device Sequence Number: 1
• Product Code: MTF
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/09/2019
• Device Catalogue Number: 07K70-27
• Device Lot Number: 84190FN00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/14/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 84 YR