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

Model Number	07K68-32
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer reported a falsely decreased architect cea result for a patient.The patient was tested previously and generated a cea result of 50 ng/ml.On (b)(6) 2020, the patient sample was tested on the architect i2000sr analyzer and generated a result of less than 0.5 ng/ml.The patient sample was then repeated on the alinity i platform and generated a result of 61 ng/ml and repeat result of 61 ng/ml.Then the customer repeated the sample back on the architect i2000sr analyzer and generated a result of 56 ng/ml.There was no impact to patient management reported.
Additional Manufacturer Narrative
The complaint investigation for the observed potential false depressed cea result included a search for similar complaints, and review of complaint text, trending data, labeling, and device history records.Return testing was not completed as returns were not available.Performance of reagent lot 10428fn00 was evaluated using worldwide data.The patient data was analyzed and compared to an established control limit.This evaluation indicated that the patient median result for lot 10428fn00 is within the established control limits, therefore, no unusual reagent lot performance was identified.Trending review determined no trends were identified for the issue for the product.Device history record review on lot 10428fn00 did not show any potential non-conformances, or deviations.Labeling was reviewed and found to adequately address the issue under review.Based on the investigation, no systemic issue or deficiency of the architect cea assay, lot number 10428fn00 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: 10864619
• Report Number: 3008344661-2020-00121
• Device Sequence Number: 19483459
• Product Code: DHX
• UDI-Device Identifier: 00380740014582
• UDI-Public: 00380740014582
• Combination Product (Y/N): N
• PMA/510(K) Number: K990774
• Number of Events Summarized: 1
• Summary Report (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): 01/28/2021

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: 04/25/2021
• Device Model Number: 07K68-32
• Device Catalogue Number: 07K68-32
• Device Lot Number: 10428FN00
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/09/2020
• Supplement Date Received by Manufacturer: 01/27/2021
• Initial Report FDA Received Date: 11/18/2020
• Supplement Report FDA Received Date: 01/28/2021
• 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 I2000SR RECONDIT KO, 03M74-65, ISR51257.; ARC I2000SR RECONDIT KO, 03M74-65, ISR51257.