MAUDE Adverse Event Report: ABBOTT IRELAND ARCHITECT CEA REAGENT KIT; SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN

Model Number	07K68-27
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Multiple patients involved in this event.No patient/sample identifier or demographic information was provided for any patient.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer questioned architect cea results for two patients.The following information was provided: person 1: cea (b)(6) 2021 11:19 result 2.37 ng/ml.Cea (b)(6) 2021 12:02 result 4.74 ng/ml.Person 2: cea (b)(6) 2021 11:41 result 2.24 ng/ml.Cea (b)(6) 2021 12:36 result 6.79 ng/ml.No impact to patient management was reported.
Additional Manufacturer Narrative
An investigation was performed for falsely depressed cea (carcinoembryonic antigen) when using architect cea, lot 26467fn00.A review of tickets was performed and did not identify an increase in complaint activity for the lot for this issue.A review of tracking and trending did not identify any trends related to the complaint issue.Return testing was not completed as returns were not available.Review of field data was performed.The median patient population result for lot 26467fn00 is comparable with all other lots in the field and confirms no systemic issue for the lot and issue under review.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.A review of labeling concluded that the issue is sufficiently addressed.Based on the investigation no systemic issue or deficiency of the architect cea, lot 26467fn00 was identified.

• Brand Name: ARCHITECT CEA REAGENT KIT
• Common Device Name: SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN
• Manufacturer (Section D): ABBOTT IRELAND; finisklin business park; sligo F91VY 44; EI F91VY44
• Manufacturer (Section G): ABBOTT IRELAND; finisklin business park; sligo F91VY 44; EI F91VY44
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford, IL N39 E-932 ; 2246682940
• MDR Report Key: 13091149
• Report Number: 3008344661-2021-00223
• Device Sequence Number: 2071798
• 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
• Serviced by Third Party (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): 03/07/2022

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: 10/20/2022
• Device Model Number: 07K68-27
• Device Catalogue Number: 07K68-27
• Device Lot Number: 26467FN00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/07/2021
• Supplement Date Received by Manufacturer: 02/09/2022
• Initial Report FDA Received Date: 12/27/2021
• Supplement Report FDA Received Date: 03/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2021
• Is the Device Labeled for Single Use? (Y/N): No
• 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: ARC I1000SR MOD, 01L86-01, I1SR54137; ARC I1000SR MOD, 01L86-01, I1SR54137
• Patient Sex: Unknown