MAUDE Adverse Event Report: ABBOTT IRELAND ARCHITECT CEA; CARCINOEMBRYONIC ANTIGEN

Catalog Number	07K68-32
Medical Device Problem Code	Incorrect Or Inadequate Test Results (2456)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed inconsistent carcinoembryonic antigen (cea) results while using the architect cea reagents.The following data was provided for the same patient.The customer uses reference range 0 to 5 ng/ml.Sid (b)(6) (tested (b)(6) 2017) 20, repeat at another facility using the abbott method 2.79 sid (b)(6) was tested (b)(6) 2017 and the result was 2.51.The patient had been previously diagnosed with gastric cancer, and tests were being done postoperatively (gastric cancer resection).No impact to patient management was reported.
Additional Manufacturer Narrative
A correction was obtained regarding the abbott method results for the patient.Describe event or problem was corrected.Review of the updated test results determined that the issue is no longer a reportable event.
Event or Problem Description
Correction february 14, 2018.The architect method results are as follows: sid (b)(6) (tested (b)(6) 2017) 2.99 ng/ml, tested at another facility using the architect method 2.79 ng/ml previous result for the patient, sid (b)(6) (tested (b)(6) 2017) 2.51 ng/ml.None of the architect results were 20 ng/ml.

• Brand Name: ARCHITECT CEA
• Common Device Name: CARCINOEMBRYONIC ANTIGEN
• Manufacturer (Section D): ABBOTT IRELAND; diagnostics division; finisklin business park; sligo NA ; EI NA
• MDR Report Key: 7075947
• Report Number: 3008344661-2017-00098
• Device Sequence Number: 19151244
• Product Code: DHX
• UDI-Device Identifier: 00380740014582
• UDI-Public: (01)00380740014582(17)181019(10)76020FN00
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K990774
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 07K68-32
• Device Lot Number: 76020FN00
• Initial Date Received by Manufacturer: 11/12/2017
• Supplement Date Received by Manufacturer: 02/14/2018
• Initial Report FDA Received Date: 12/01/2017
• Supplement Report FDA Received Date: 02/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1