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

Catalog Number	07K68-27
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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 reported false decreased architect cea result for a recently diagnosed colon cancer patient.The following cea results were provided: 10/18: 6.6 ng/ml; 12/4: 4.8 ng/ml.The customer reports no treatment was done.No impact to patient management was reported.
Additional Manufacturer Narrative
Further investigation of the customer issue included a review of complaint text, a search for similar complaints, review of field data, and a review of labeling.A complaint trending review determined no adverse trend, nonconformances, or potential nonconformances were identified for the customer issue.Review of data determined that the patient median result for the likely cause product lot is comparable with other lots in the field and no systemic issue was identified.A review of the product quality history for the lot number did not identify issues associated with the customer observation.Labeling was reviewed and found to be adequate.No return patient sample was available.Based on all available information and abbott diagnostics complaint investigation no product deficiency was identified.

• 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: 8225989
• Report Number: 3008344661-2019-00004
• Device Sequence Number: 14019875
• Product Code: DHX
• UDI-Device Identifier: 00380740014575
• UDI-Public: 00380740014575
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2019

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 Expiration Date: 01/11/2019
• Device Catalogue Number: 07K68-27
• Device Lot Number: 88126FN00
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/11/2018
• Supplement Date Received by Manufacturer: 01/22/2019
• Initial Report FDA Received Date: 01/08/2019
• Supplement Report FDA Received Date: 02/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARCHITECT I2000SR, LIST 03M74-01; ARCHITECT I2000SR, LIST 03M74-01; SERIAL (B)(4); SERIAL (B)(4)