MAUDE Adverse Event Report: ABBOTT GMBH ARCHITECT CA19-9XR REAGENT KIT; SYSTEM, TEST, CARBOHYDRATE AG (CA19-9), FOR MONIT AND MGMT OF PANCREATIC CANCER

Catalog Number 02K91-32

Device Problem High Test Results (2457)

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

Event Date 12/23/2020

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.There was no additional patient information provided by the customer.This report is being filed on an international product, list number 2k91-32 that has a similar product distributed in the us, list number 2k91-33.

Event Description

The customer reported falsely elevated architect ca19-9 result on one patient.The results provided were: on (b)(6) 2020 initial ca19-9 = 103.29u/l / retest = 127.70u/l, cea = 5.67ng/ml; previous results (b)(6) 2020 /(b)(6) 2020 ca19-9 = 17u/ml, cea = 5.0 ng/ml.The cea results provided are not discrepant.The patient is being monitored after cancer treatment (unknown what type of cancer).There was no change to patient treatment.There was no reported adverse impact to patient management.

Manufacturer Narrative

The complaint investigation was performed for observed falsely elevated results which included a search for similar complaints, review of complaint text, trending data, labeling, device history records, and historical performance of the reagent lot.Return testing was not completed as returns were not available.Trending review determined no trends for the issue for the product.Device history record review of lot 13008m800 did not show any potential non-conformances, deviations, or non-conformances related to the issue.Labelling was reviewed and found to adequately address the issue.Historical performance in the field of lot 13008m800 using worldwide data through abbottlink was evaluated.The field data review showed that the median patient result is within established limits, indicating that the lot is performing as expected.Based on the investigation, no systemic issue or deficiency of the architect ca 19-9xr reagent, lot 13008m800, was identified.

• Brand Name: ARCHITECT CA19-9XR REAGENT KIT
• Type of Device: SYSTEM, TEST, CARBOHYDRATE AG (CA19-9), FOR MONIT AND MGMT OF PANCREATIC CANCER
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 11250751
• MDR Text Key: 229392633
• Report Number: 3002809144-2021-00070
• Device Sequence Number: 1
• Product Code: NIG
• Combination Product (y/n): N
• PMA/PMN Number: K052000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 02/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/06/2021
• Device Catalogue Number: 02K91-32
• Device Lot Number: 13008M800
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2K PROC MOD, 03M74-01, (B)(6); ARC I2K PROC MOD, 03M74-01, (B)(6); ARC I2K PROC MOD, 03M74-01, (B)(4)