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

Model Number 07K68-35

Device Problem Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/26/2022

Event Type  malfunction  

Event Description

The customer suspects falsely depressed architect cea and architect ca 19-9xr results for a patient.The following data was provided: on (b)(6)2021: cea: 11.3 ng/ml / ca19-9 result: 246.2 u/ml on (b)(6)2022: cea: 16.3 ng/ml / ca 19-9 result: 166.6 u/ml on (b)(6)2022 sid(b)(6): cea result: 4.38 ng/ml, ca 19-9 result: 22.32 u/ml retested on (b)(6)2022: cea result: 4.42 ng/ml, ca 19-9 result: 26.5 u/ml the patient¿s clinical history is unknown and doctor suspects may¿s results are low.There was no impact to patient management reported.

Manufacturer Narrative

All available patient information is included.Additional patient details are not available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Manufacturer Narrative

The complaint investigation for falsely depressed architect cea results included a search for similar complaints, and the review of complaint text, trending data, labeling, and device history records.Return testing was not performed as returns were not available.A review of tracking and trending did not identify any related trends for the lot number 37456fn00 and the complaint issue.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.The ticket search by lot indicates that the reagent lot performs as expected for this product.Customer field data was used to assess the performance of the architect cea assay using worldwide data.The median patient population result for lot 37456fn00 is comparable with all other lots in the field and falls within established baselines, confirming no systemic issue for the lot.The device history records were reviewed and did not identify any non-conformances or deviations associated with the lot number and complaint issue.Labeling was reviewed and adequately addresses the issue under review.Based on the investigation, no systemic issue or product deficiency for architect cea reagent lot 37456fn00 was identified.

• Brand Name: ARCHITECT CEA REAGENT KIT
• Type of Device: 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 N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 14658197
• MDR Text Key: 300154399
• Report Number: 3008344661-2022-00064
• Device Sequence Number: 1
• Product Code: DHX
• UDI-Device Identifier: 00380740112424
• UDI-Public: 00380740112424
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K990774
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: 07K68-35
• Device Catalogue Number: 07K68-35
• Device Lot Number: 37456FN00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2K PROC MOD, 03M74-01, (B)(6) ; ARC I2K PROC MOD, 03M74-01, (B)(6)