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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.
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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 Key5766461
MDR Text Key49388356
Report Number1415939-2016-00072
Device Sequence Number1
Product Code NIG
Combination Product (y/n)N
Reporter Country CodeFR
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 04/14/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/01/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/23/2016
Device Catalogue Number02K91-23
Device Lot Number50354M500
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 Received04/13/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage