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

Catalog Number	07K68-35
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/02/2018
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.An evaluation is in-process.
Event or Problem Description
The customer observed erratic results while using the architect cea assay.The customer provided the following results data: on (b)(6) 2018 cea initial 0.5, retest 4.4 ng/ml there was no impact to patient management reported.No additional patient information was available.
Additional Manufacturer Narrative
Evaluation of the customer issue included a review of the complaint text, field data review, a design history record (dhr) review, a search for similar complaints, and a review of labeling.Return material was not available.An analysis utilizing customer field data was used to assess the specificity of the assay.Instrument data analytics (ida) reports for list the architect cea assay were reviewed to determine if the median patient values have shifted over time.The analysis concluded that all reagent lots read patient results consistently therefore determined the reagent is performing acceptably.The dhr review did not identify any potential non-conformances, non-conformances or deviations related to the complaint issue.Tracking and trending did not identify an adverse trend.Labeling was reviewed and found to be adequate.Based on the available information no product deficiency of the architect cea reagent, list number 07k68, 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: 7426437
• Report Number: 3008344661-2018-00030
• Device Sequence Number: 19218046
• Product Code: DHX
• UDI-Device Identifier: 00380740112424
• UDI-Public: 00380740112424
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2018

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 Catalogue Number: 07K68-35
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/20/2018
• Supplement Date Received by Manufacturer: 08/07/2018
• Initial Report FDA Received Date: 04/12/2018
• Supplement Report FDA Received Date: 08/24/2018
• 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; ARCHITECT I2000SR ANALYZER; LN 03M74, SN ISR06379; LN 03M74, SN ISR06379