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 09/06/2018

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.An evaluation is in process.

Event Description

The customer observed falsely depressed results while using architect total psa (prostate specific antigen) reagents.The following data was provided for the same patient.Sid (b)(6) initial 0.83 ng/ml, repeat 0.80, 0.79, 0.74 ng/ml, repeat in another laboratory 0.71, 0.61, 0.83, 0.88 ng/ml.Sid (b)(6) initial 1.19 ng/ml, not repeated.Sid (b)(6) initial 2.02 ng/ml, not repeated.Sid (b)(6) initial 1.16 ng/ml, not repeated.Sid (b)(6) initial 3.38 ng/ml, not repeated.Sid (b)(6) initial 1.09 ng/ml, not repeated.Sid (b)(6) initial 4.57 ng/ml, not repeated.Sid (b)(6) initial 7.23 ng/ml, not repeated.Sid (b)(6) initial 0.74 ng/ml, not repeated.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: 7954341
• MDR Text Key: 125464902
• Report Number: 3008344661-2018-00085
• Device Sequence Number: 1
• Product Code: LTJ
• Combination Product (y/n): N
• Reporter Country Code: AR
• 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: 10/10/2018

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 Catalogue Number: 07K70-30
• Device Lot Number: 85185FN00
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/20/2018
• Initial Date FDA Received: 10/10/2018
• Was Device Evaluated by Manufacturer?: No
• 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: 41 YR