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

Catalog Number 02K91-38

Device Problem High Test Results (2457)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 02k91-38 that has a similar product distributed in the us, list number 2k91-27.

Event Description

The customer observed falsely elevated ca 19-9 results generated using the architect ca 19-9xr reagents.The following data was provided (u/ml).Initial (no sid) 113.89.Repeat with a different sample ((b)(6)) less than 0.2 in duplicate.Repeat (no sid) repeat 137.99, 135.Roche method showed negative results, 29.59.The patient received a gastroscopy (upper gastro intestinal endoscopy) that found no abnormalities.The patient gastrointestinal tract was normal during a physical examination.The patient was not being monitored for pancreatic cancer.

Manufacturer Narrative

(b)(4), no code available, unnecessary endoscopy.Evaluation of the customer issue included a review of the complaint text, a search for similar complaints, a review of labeling, and accuracy testing.No adverse trend was identified for the customer issue.Labeling was reviewed and found to be adequate.Returns were not available.Clinical accuracy testing was performed using an internal panel and in-house retained kits of the likely cause reagent lot stored at the recommended storage condition.Accuracy testing met all specifications.Based on all available information and abbott diagnostics complaint investigation, the assay performed as intended and no product deficiency was identified.

Manufacturer Narrative

The device evaluation was reassessed and concluded that a malfunction occurred, the device did not perform as intended.However, no systematic issue or product deficiency was identified.

• Brand Name: ARCHITECT CA 19-9XR
• Type of Device: CA 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: 5833232
• MDR Text Key: 50745577
• Report Number: 1415939-2016-00081
• Device Sequence Number: 1
• Product Code: NIG
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K052000
• 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,Followup,Followup
• Report Date: 05/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/11/2016
• Device Catalogue Number: 02K91-38
• Device Lot Number: 50410M500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2016
• 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
• Treatment: SERIAL NUMBER (B)(4)
• Patient Outcome(s): Other