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 Consequences Or Impact To Patient (2199)
Date of Event	07/15/2020
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 was no additional patient information provided.
Event or Problem Description
The customer stated that a falsely decreased architect cea result of 0.9 ng/ml was generated on (b)(6) 2020, and did not match the patient's historical or subsequent testing.The sample was not available for repeat testing.Sid: (b)(6): 0.9 ng/ml; (b)(6) 2020.Sid: (b)(6): 3329.7 ng/ml; (b)(6) 2020.(agrees with previous tests and patient history).No adverse impact to patient management was 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, labelling, and device history records.Return testing was not completed as returns were not available.Performance of reagent lot 09006fn00 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 09006fn00 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.Device history record review on lot 09006fn00 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 09006fn00 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: 10549756
• Report Number: 3008344661-2020-00071
• Device Sequence Number: 11546884
• Product Code: DHX
• UDI-Device Identifier: 00380740014575
• UDI-Public: 00380740014575
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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): 12/02/2020

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: 03/30/2021
• Device Model Number: 07K68-27
• Device Catalogue Number: 07K68-27
• Device Lot Number: 09006FN00
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/28/2020
• Supplement Date Received by Manufacturer: 11/11/2020
• Initial Report FDA Received Date: 09/17/2020
• Supplement Report FDA Received Date: 12/03/2020
• 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: ARC I2000SR INST, 03M74-02, ISR62633; ARCHITECT I2000SR ANALYZER, LN 03M74-02; SN (B)(6); ARCHITECT I2000SR ANALYZER, LN 03M74-02; SN (B)(4)