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

Model Number	07K68-35
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2022
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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.
Additional 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
• 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 N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 14658197
• Report Number: 3008344661-2022-00064
• Device Sequence Number: 14387432
• Product Code: DHX
• UDI-Device Identifier: 00380740112424
• UDI-Public: 00380740112424
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2022

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: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/27/2022
• Supplement Date Received by Manufacturer: 08/09/2022
• Initial Report FDA Received Date: 06/10/2022
• Supplement Report FDA Received Date: 08/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2022
• 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 I2K PROC MOD, 03M74-01, (B)(6) ; ARC I2K PROC MOD, 03M74-01, (B)(6)
• Patient Sex: Unknown