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

Model Number	07K68-32
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/09/2020
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 stated that a falsely decreased architect cea result of 0.53 ng/ml was generated for a patient sample that retested at 3.98 and 5.15 ng/ml.No adverse impact to patient management was reported.
Additional Manufacturer Narrative
A review of tickets determined there is normal complaint activity for lot 96156fn00.Tracking and trending report review determined there are no related trends for the architect cea reagent.Field data was reviewed to assess the performance of the architect cea reagent and the median population for lot 96156fn00 was noted to be comparable with all other lots in the field, confirming no systemic issue for the specific lot.Manufacturing documentation was reviewed and no issues were noted.Additionally, labeling was reviewed and adequately addresses the customer issue.Within the limitations of the procedure section of the product package insert, a serum or plasma cea level, regardless of value, should not be interpreted as absolute evidence for the presence or absence of malignant disease.The cea level should be used in conjunction with information available from clinical evaluation and other diagnostic procedures.Based on the investigation, no systemic issue or product deficiency was identified for the architect cea reagent.

• Brand Name: ARCHITECT CEA
• Common Device Name: CARCINOEMBRYONIC ANTIGEN
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION; finisklin business park; diagnostics division; sligo NA ; EI NA
• MDR Report Key: 9643790
• Report Number: 3008344661-2020-00009
• Device Sequence Number: 14078535
• Product Code: DHX
• UDI-Device Identifier: 00380740014582
• UDI-Public: 00380740014582
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• 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): 02/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/15/2020
• Device Model Number: 07K68-32
• Device Catalogue Number: 07K68-27
• Device Lot Number: 96156FN00
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/09/2020
• Supplement Date Received by Manufacturer: 02/14/2020
• Initial Report FDA Received Date: 01/29/2020
• Supplement Report FDA Received Date: 02/25/2020
• 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 I1000SR ANALYZER; ARCHITECT I1000SR, LN 01L86-01; LN01L86-01, (B)(6); SN (B)(6)