MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT TOTAL PSA

Catalog Number 07K70-25

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2014

Event Type  malfunction  

Event Description

The account generated a falsely elevated architect total psa of 6.92 ng/ml on a patient 3 months after prostate removal.The physician expected the patient's total psa value to be close to 0.00 ng/ml.The account uses a normal total psa range of <4.00 ng/ml.No specific patient information was provided.No impact to patient management was reported.

Manufacturer Narrative

This report is being filed on an international product list number 7k70, that has a similar product distributed in the us, list number 6c06.(b)(4).An evaluation is in process.A followup report will be submitted when the evaluation is complete.Evaluation in process.

Manufacturer Narrative

The complaint trending report review determined that there is no non statistical or adverse trend for the product.As no patient sample was available to assist us in the investigation, and the lot number was unknown, testing of a serum based panel sample using retained kits of lots 37445lf00 and 36275lf00 was performed.All specifications were met indicating that both lots are performing acceptably.A review of the manufacturing documentation did not identify any issues associated with the customer observation.A review of the product labeling concluded that the issue is sufficiently addressed.Based on all available information, the investigation determined the assay performed as intended and no product deficiency was identified.

Manufacturer Narrative

Upon retrospective review, it was discovered the site of manufacture, was incorrectly chosen as (b)(4).Mfr # 3008344661-2016-00041 is to correct the site of manufacture to (b)(4).Any further information or followup will be submitted under mfr # 3008344661-2016-00041.

• Brand Name: ARCHITECT TOTAL PSA
• Type of Device: TOTAL PSA
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 3500
• Manufacturer (Section G): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 3500
• 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: 4014684
• MDR Text Key: 4691092
• Report Number: 1415939-2014-00183
• 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,foreign,health professi
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07K70-25
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SERIAL (B)(4); ARCHITECT I2000SR LIST 03M74-01; SERIAL (B)(4); ARCHITECT I2000SR LIST 03M74-01