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	08/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 results generated on an architect i2000 processing module on a (b)(6) male undergoing radiation therapy for lung cancer.The following results were provided.Sid (b)(6) initial result = 1.47 ng/ml, repeat result = 32.63 ng/ml.The patient had been trending around 30 ng/ml.There was no impact to patient management reported.
Additional Manufacturer Narrative
The complaint investigation 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.Return testing was not completed as returns were not available.Trending review did not identify any trends for the likely cause lot or complaint issue.Device history record review did not identify any non-conformances or deviations for the likely cause lot.The overall performance of architect cea reagent in the field was reviewed using data gathered from customers worldwide.The median patient population result for lot 26467fn00 is comparable with all other lots in the field and within established baselines.Labeling was reviewed and sufficiently addresses the customer¿s issue.No systemic issue or deficiency with the architect cea reagent 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
• MDR Report Key: 12433509
• Report Number: 3008344661-2021-00164
• Device Sequence Number: 11641827
• 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): 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): 10/15/2021

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?: Yes
• Initial Date Received by Manufacturer: 08/18/2021
• Supplement Date Received by Manufacturer: 10/13/2021
• Initial Report FDA Received Date: 09/07/2021
• Supplement Report FDA Received Date: 10/15/2021
• 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, ISR50257; ARC I2K PROC MOD, 03M74-01, ISR50257; ARC I2K PROC MOD, 03M74-01, ISR50257
• Patient Age: 71 YR