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

Catalog 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
All available patient information was included.Additional patient details are not available.An evaluation is in process.A final report will be submitted when the evaluation is complete.
Event or Problem Description
The customer reported false decreased cea results when processing on the architect i2000sr for sid (b)(6).The initial result was 0.5 and retest was 22.0.Previous results were 15.6 and 8.5.No impact to patient management was reported.
Additional Manufacturer Narrative
A review of complaint activity determined that there was normal complaint activity for the likely cause lot 90357fn00.Tracking and trending report review for the architect cea assay determined that there were no trends identified.Since no patient sample was available for testing, a serum-based panel of samples, which mimics a patient sample, was performed using a retained kit of lot 90357fn00; all specifications were met, and the lot performed acceptably.Field data was reviewed and determined the patient median result for lot 90357fn00 is comparable with other lots in the field.Manufacturing documentation was reviewed and did not identify any issues.Additionally, labeling was reviewed and sufficiently addresses the customer issue.Based on the investigation, no systemic issue or deficiency of the architect cea assay was identified.

• Brand Name: ARCHITECT CEA
• Common Device Name: CARCINOEMBRYONIC ANTIGEN
• Manufacturer (Section D): ABBOTT IRELAND; diagnostics division; finisklin business park; sligo NA ; EI NA
• MDR Report Key: 8549033
• Report Number: 3008344661-2019-00053
• Device Sequence Number: 19265228
• Product Code: DHX
• UDI-Device Identifier: 00380740014575
• UDI-Public: 00380740014575
• 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: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2019

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: 01/24/2020
• Device Catalogue Number: 07K68-27
• Device Lot Number: 90357FN00
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/29/2019
• Supplement Date Received by Manufacturer: 08/26/2019
• Initial Report FDA Received Date: 04/25/2019
• Supplement Report FDA Received Date: 08/26/2019
• 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, LN 03M74-02; ARCHITECT I2000SR, LN 03M74-02; SERIAL (B)(4).; SERIAL (B)(4).