MAUDE Adverse Event Report: ABBOTT IRELAND ARCHITECT TOTAL PSA

Catalog Number 07K70-27

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/19/2017

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer stated that falsely elevated architect total psa result of 13.67 ng/ml was generated for a (b)(6) year old male patient on (b)(6) 2017.Testing was performed at another hospital (method not specified) on (b)(6)2017 and the patient's total psa result was 2.75 ng/ml.Repeat testing on architect was 13.12 ng/ml.No adverse impact to patient management was reported.

Manufacturer Narrative

No customer returns were available.Investigation of the customer issue included a review of the complaint text, a search for similar complaints and a review of labeling.Historical quality metrics were reviewed and no adverse trend was identified for the customer's issue.Complaint searches determined that there is normal complaint activity for the likely cause lot.Labeling was reviewed and found to be adequate.Testing of a serum based panel sample with a target concentration of 3.5 ng/ml, which mimics a patient sample, was performed using an in-house retained kit of lot 73007fn00 stored at the recommended storage condition.All specifications were met indicating that lot 73007fn00 is performing acceptably.Historical performance of the reagent lot was evaluated using world wide data from abbott link.The patient data was analyzed and compared to an established control limit.This evaluation indicated that the patient median result for this lot is within the established control limits which indicates that the lot is performing acceptably and comparable to other lots in the field.Based on the available information, no product deficiency of architect total psa, lot number 73007fn00, 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: 6747912
• MDR Text Key: 81192468
• Report Number: 3008344661-2017-00071
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/30/2017

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: 01/23/2018
• Device Catalogue Number: 07K70-27
• Device Lot Number: 73007FN00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/13/2017
• Initial Date FDA Received: 07/27/2017
• Supplement Dates Manufacturer Received: 08/29/2017
• Supplement Dates FDA Received: 08/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/20/2017
• 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
• Treatment: ARCHITECT I2000SR ANALYZER; LIST 03M74-01, SERIAL (B)(4)
• Patient Age: 52 YR