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	12/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Completed information for patient identifier: (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed falsely depressed architect cea (carcinoembryonic antigen) results for a (b)(6) male diagnosed with digestion visceral cancer.The following data was provided: on (b)(6) 2021, sid (b)(6), initial result was >1500 ng/ml, repeat = 9.7 ng/ml, repeat with a dilution = 2114.7 ng/ml.No impact to patient management was reported.
Additional Manufacturer Narrative
The complaint investigation for falsely depressed architect cea results included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review, and field data review.Trending review did not identify any trends for the issue for the product.Device history record review did not identify any non-conformances or deviations with lot 26470fn00 and the complaint issue.The overall performance of architect cea was reviewed using field data from customers worldwide.The median patient population result for lot 26470fn00 is comparable with all other lots in the field and confirms no systemic issue for the lot.Labeling was reviewed and found to be adequate.Based on our investigation, no systemic issue or deficiency with the architect cea reagent for lot 26470fn00 was identified.
Event or Problem Description
The customer observed falsely depressed architect cea (carcinoembryonic antigen) results for a 67 year old male diagnosed with digestion visceral cancer.The following data was provided: 01dec2021 sid (b)(6) initial result was >1500 ng/ml, repeat = 9.7 ng/ml, repeat with a dilution = 2114.7 ng/ml no impact to patient management was reported.

• 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: christian lee ; 100 abbott park road; dept. 09b9, lc cp01-3; abbott park, IL 60064-3537 ; 2246682940
• MDR Report Key: 13028546
• Report Number: 3008344661-2021-00214
• Device Sequence Number: 19273928
• 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): 01/12/2022

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: 10/12/2022
• Device Model Number: 07K68-35
• Device Catalogue Number: 07K68-35
• Device Lot Number: 26470FN00
• 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: 12/01/2021
• Supplement Date Received by Manufacturer: 01/11/2022
• Initial Report FDA Received Date: 12/17/2021
• Supplement Report FDA Received Date: 01/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2021
• 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 I2K PROC MOD, 03M74-01, (B)(6).; ARC I2K PROC MOD, 03M74-01, (B)(6).
• Patient Sex: Unknown