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

Catalog Number 02K91-28

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.

Event Description

The customer observed falsely elevated ca 19-9 results generated with the architect ca 19-9xr reagents.The following data was provided (u/ml).Tested in (b)(6) 2016: 548.Previous results provided were 122 ((b)(6) 2016), 85, ((b)(6) 2016), 98 ((b)(6) 2016), and 77, (b)(6) 2016.The patient was diagnosed with diabetes , hyperlipidemia, and hypertension.Diagnostic tests including ct, echo, mri, and pet were completed after the elevated (b)(6) 2016 test and showed no tumor.Iv contrast (18f-fdg (the fluoro-deoxy-glucose) was administered for the positron emission tomography (pet) scan.The patient was not diagnosed with and was not being monitored for pancreatic cancer.No further impact to patient management was reported and no further details are known.The event caused unnecessary administration of iv contrast for a pet scan.

Manufacturer Narrative

Investigation 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 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.

• 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: 5695853
• MDR Text Key: 46464560
• Report Number: 1415939-2016-00061
• Device Sequence Number: 1
• Product Code: NIG
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 06/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/23/2016
• Device Catalogue Number: 02K91-28
• Device Lot Number: 50376M500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2015
• 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
• Patient Outcome(s): Other
• Patient Age: 64 YR