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Catalog Number 02K91-38
Device Problem High Test Results (2457)
Patient Problem No Code Available (3191)
Event Date 07/15/2016
Event Type  malfunction  
Manufacturer Narrative
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. An evaluation is in process.
Event Description
The customer observed falsely elevated ca 19-9 results for one patient generated using architect ca 19-9xr reagents. The following data was provided (u/ml). Sid (b)(6) tested (b)(6) 2016 initial 179, not repeated. Other methods showed lower results 16, 15. 3, and 13, however the specific methods were not provided. Previous test results were provided for the patient: sid (b)(6) tested on (b)(6) 2016 initial 158, repeat 196. Sid (b)(6) tested on (b)(6) 2016 initial 1062, repeat 1101. Sid (b)(6) tested on (b)(6) 2016 initial 139, repeat 155. The patient was not being monitored for pancreatic cancer. The patient underwent a colonoscopy and pet scan.
Manufacturer Narrative
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's issue. Labeling was reviewed and found to be adequate. The architect ca19-9 package insert includes the intended use of this assay is an aid in the management of pancreatic cancer patients. Information provided by the customer indicated that patient did not have pancreatic cancer, and the assay was being used outside the intended use. 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, the device did not perform as intended. However, no systematic issue or product deficiency was identified. Conclusion code was corrected.
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Type of DeviceCA 19-9
Manufacturer (Section D)
100 abbott park road
abbott park IL 60064 3500
Manufacturer (Section G)
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
MDR Report Key5892500
MDR Text Key52621697
Report Number1415939-2016-00088
Device Sequence Number1
Product Code NIG
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/01/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/20/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/23/2016
Device Catalogue Number02K91-38
Device Lot Number50405M500
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 Received04/17/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/01/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 08/20/2016 Patient Sequence Number: 1