MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT CA 19-9XR; CANCER ANTIGEN 19-9

Catalog Number 02K91-32

Device Problem Low Test Results (2458)

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

Event Date 07/28/2017

Event Type  malfunction  

Manufacturer Narrative

A review of complaint tracking and trending metrics was performed and identified no adverse trends in conjunction with the complaint issue currently under evaluation.No non-conformances or deviations associated with the affected reagent lot were identified.An in-house retained reagent kit of architect ca 19-9xr reagent, lot number 73036m800, was tested in an accuracy performance setup.Results from this testing did not implicate that the accuracy performance of the lot is negatively impacted.All acceptance criteria met specifications.No returns were made available from the customer site.The architect ca 19-9xr assay package insert contains information to address the current customer issue.Based on the results of this evaluation and the information from the customer site, no systemic issue or product deficiency was identified.This report is being filed on an international product, list number 02k91-32, that has a similar product distributed in the us, list number 02k91-29.Pt identifier: sid (b)(6).This issue was previously reported under mdr number 3002809144-2017-00114 under a different suspect device manufacturer.

Event Description

The customer reports the following results being generated with the architect ca 19-9xr assay for a patient diagnosed with pancreatic cancer and being monitored with samples tested on an architect i2000sr analyzer (the following results are from the same patient tested on (b)(6) 2017): sid (b)(6): 1.81 u/ml.Sid (b)(6): 79.96 u/ml.Sid (b)(6): 61.54 u/ml.Controls have remained within specifications.No suspect results have been reported from the lab.There is no impact to patient management reported.

• Brand Name: ARCHITECT CA 19-9XR
• Type of Device: CANCER ANTIGEN 19-9
• 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: 7043482
• MDR Text Key: 93214540
• Report Number: 1415939-2017-00205
• Device Sequence Number: 1
• Product Code: NIG
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 11/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/03/2018
• Device Catalogue Number: 02K91-32
• Device Lot Number: 73036M800
• 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