MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ARCHITECT CEA; CARCINOEMBRYONIC ANTIGEN

Model Number	07K68-27
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information: no specific patient information was provided.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer obtained a falsely depressed architect cea result.Sample 1 generated a result of 4.69 ng/ml on the current lot and when retested on a new log generated 6.37 ng/ml.No impact to patient management was reported.
Additional Manufacturer Narrative
The complaint investigation for potential false depressed cea results included a search for similar complaints, and review of complaint text, trending data, labelling, device history records and field data review.Return testing was not completed as returns were not available.Performance of reagent lot 04200fn00 was evaluated using world wide field data.The patient data was analyzed and compared to an established control limit.This evaluation indicated that the patient median result for lot 04200fn00 is within the established limits, therefore, no unusual reagent lot performance was identified.Trending data for the architect cea assay was reviewed and identified no trends associated with the issue.Device history record review for lot 04200fn00 did not show any potential non-conformances, or deviations.Labeling was reviewed and found to adequately address the issue under review.Additionally, the customer issue was resolved when lot 04200fn00 was recalibrated.Based on the investigation, no systemic issue or deficiency of the architect cea assay, lot number 04200fn00 was identified.

• Brand Name: ARCHITECT CEA
• Common Device Name: CARCINOEMBRYONIC ANTIGEN
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION; finisklin business park; diagnostics division; sligo NA ; EI NA
• MDR Report Key: 10290798
• Report Number: 3008344661-2020-00060
• Device Sequence Number: 2246206
• Product Code: DHX
• UDI-Device Identifier: 00380740014575
• UDI-Public: 00380740014575
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 09/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/13/2020
• Device Model Number: 07K68-27
• Device Catalogue Number: 07K68-78
• Device Lot Number: 04200FN00
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/06/2020
• Supplement Date Received by Manufacturer: 09/11/2020
• Initial Report FDA Received Date: 07/17/2020
• Supplement Report FDA Received Date: 09/15/2020
• 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: ARCHITECT I2000SR, LIST 03M74-02,; ARCHITECT I2000SR, LIST 03M74-02,; SERIAL (B)(6) ; SERIAL (B)(6)