MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT CA19-9XR REAGENTS

Catalog Number 02K91-32

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Type  malfunction  

Manufacturer Narrative

Evaluation of the customer issue included a review of the complaint text, a search for similar complaints, labeling review, and accuracy testing.No adverse trend was identified for the customer issue.Labeling was reviewed and found to be adequate.No returns were available.An internal panel was tested with retained kits of the likely cause reagent lot and accuracy testing met all specifications.Based on all available information and abbott diagnostics evaluation, no systematic issue was identified and no product deficiency was identified.This report is being filed on an international product, list number 2k91-32 that has a similar product distributed in the us, list number 2k91-29.This issue was previously reported under mdr number 3002809144-2017-00110 under a different suspect device manufacturer.

Event Description

The customer observed falsely elevated ca19-9 results for one patient while using the architect ca19-9xr reagents.The following data was provided (u/ml).(b)(6) initial 8.40, repeat 86.08, 8.40.No impact to patient management was reported.

• Brand Name: ARCHITECT CA19-9XR REAGENTS
• Type of Device: CA19-9
• 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: 7039373
• MDR Text Key: 93063981
• Report Number: 1415939-2017-00202
• Device Sequence Number: 1
• Product Code: NIG
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2017
• Device Catalogue Number: 02K91-32
• Device Lot Number: 73035M800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2017
• 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