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 Consequences Or Impact To Patient (2199)
Date of Event	01/05/2021
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.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer observed a falsely decreased architect cea result of <0.5 ng/ml for a patient sample that retested at 1130 ng/ml.No adverse impact to patient management was reported.
Additional Manufacturer Narrative
This follow up is submitted to populate fields d8 and/or h6 with data that had previously been provided in field h10.There is no change to the content of the data.
Additional Manufacturer Narrative
Health effect impact code: f26.Component code: g01003.D8.Was this device serviced by a third party? no.The complaint investigation for the observed potential false depressed cea result included a search for similar complaints, and review of complaint text, trending data, labelling, and device history records.Return testing was not completed as returns were not available.Performance of reagent lot 19654fn00 was evaluated using world wide data from abbottlink.The patient data was analyzed and compared to an established control limit.This evaluation indicated that the patient median result for lot 19654fn00 is within the established control limits, therefore, no unusual reagent lot performance was identified.Trending review determined no adverse trend for the issue for the product.Preventive actions (capa) review on lot 19654fn00 did not show any potential non-conformances, or deviations related to the current complaint issue.Labelling 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 19654fn00, 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: 11230436
• Report Number: 3008344661-2021-00022
• Device Sequence Number: 3861740
• Product Code: DHX
• UDI-Device Identifier: 00380740014575
• UDI-Public: 00380740014575
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K990774
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/08/2021

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: 03/10/2022
• Device Model Number: 07K68-27
• Device Catalogue Number: 07K68-27
• Device Lot Number: 19654FN00
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/07/2021
• Supplement Date Received by Manufacturer: 04/06/2021; 06/07/2021
• Initial Report FDA Received Date: 01/26/2021
• Supplement Report FDA Received Date: 04/06/2021; 06/08/2021
• 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 INST, 03M74-02, ISR53511.; ARC I2000SR INST, 03M74-02, ISR53511.; ARC I2000SR INST, 03M74-02, ISR53511.; ARC I2000SR INST, 03M74-02, ISR53511