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

Catalog Number 02K91-23

Device Problem Low Test Results (2458)

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

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process. A follow up report will be submitted when the evaluation is complete. (b)(4). An evaluation is in process.

Event Description

The customer observed a falsely depressed ca19-9 result on a known patient with pancreatic cancer. The following data was provided sid (b)(6): initial 2. 8 repeat 7. 9 iu/ml (65% shift). There was no impact to patient management reported.

Manufacturer Narrative

On july 4, 2016, the suspect medical device list number changed from 02k91-28 to 02k91-23 and from lot number unknown to lot 50384m500. On july 15, 2016 the suspect medical device lot number was changed from 50384m500 to 50354m500. This was updated in model/lot#. On july 28, 2016 the evaluation was completed. Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, review of instrument logs, a review of labeling and accuracy testing. Historical performance of the reagent lot was evaluated using world wide data from abbott link. The patient data was analyzed and compared to an established control limit. This evaluation indicated that the patient median result for this lot is within the established control limits and no unusual reagent lot performance was identified. No adverse trend was identified for the customer's issue. Labeling was reviewed and found to be adequate. The product was not available for return. 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' 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, therefore, the device was not performing as intended, however, no systemic 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: 5766461
• MDR Text Key: 49388356
• Report Number: 1415939-2016-00072
• Device Sequence Number: 1
• Product Code: NIG
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K052000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 04/14/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 07/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 09/23/2016
• Device Catalogue Number: 02K91-23
• Device Lot Number: 50354M500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage