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)
Date of Event	02/13/2020
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.There is no further patient information provided due to privacy issues.
Event or Problem Description
The customer reported falsely depressed architect cea results on one patient.The results provided were: (b)(6) day 1 architect=9ng/ml/ roche = 23ng/ml; day 2 arch = 19.9ng/ml / roche = 23ng/ml.There was no reported impact to patient management.
Additional Manufacturer Narrative
A review of tickets found no other complaints for lot 09599fn00, and no trends were identified for the issue for the product.Return testing was not completed as returns were not available.Customer field data was used to assess the performance of the architect cea assay using world wide data through abbottlink.The median population result for lot 09599fn00 is comparable with all other lots in the field and falls within established baselines, confirming no systemic issue for the lot.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.A review of the product labeling concluded that the issue is sufficiently addressed.A result log from the customer's instrument, serial number (b)(4), was reviewed for cea patient test data, showing a result of 19.9ng/ml was obtained for (b)(4)on (b)(6) 2020.However, a result of 9ng/ml could not be found for this sid.The review did identify the sid had been tested on (b)(6) 2020, with a result of 19.4 ng/ml, which is consistent with the result of 19.9ng/ml generated on (b)(6) 2020.Based on the investigation no product deficiency was identified for the architect cea reagent, lot 09599fn00.

• 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: 9793537
• Report Number: 3008344661-2020-00021
• Device Sequence Number: 2185280
• Product Code: DHX
• UDI-Device Identifier: 00380740014575
• UDI-Public: 00380740014575
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 04/09/2020

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: 05/05/2021
• Device Model Number: 07K68-27
• Device Catalogue Number: 07K68-27
• Device Lot Number: 09599FN00
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/13/2020
• Supplement Date Received by Manufacturer: 04/06/2020
• Initial Report FDA Received Date: 03/05/2020
• Supplement Report FDA Received Date: 04/09/2020
• 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 ANALYZER, LN 03M74-02,; ARCHITECT I2000SR ANALYZER, LN 03M74-02,; SERIAL # (B)(4); SERIAL # (B)(4)