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 Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	06/07/2017
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.
Event or Problem Description
The customer reported they obtained a false depressed result on the architect cea assay with reagent lot 72324fn00.Sample id (b)(6) generated an initial result of 3.35 ng/ml and when repeated in duplicate (sample id (b)(6)) generated 149.00 and 142.16 ng/ml.
Additional Manufacturer Narrative
Update: patient and device codes were provided.
Additional Manufacturer Narrative
Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, in-house testing, review of manufacturing documentation and review of labeling.The customer's instrument logs were reviewed.No instrument errors were associated with the depressed cea test result; however, the sample was simultaneously being tested for ca19-9 where a sample aspiration error was generated.The sample was subsequently retested for cea and returned results which were more consistent with previous results from this patient.Further review of instrument logs also indicated a low pressure discord value during the testing of the ca19-9 replicate which returned the aspiration error.The pressure discord value for the depressed cea replicate was acceptable, but was low compared to the retest replicates.The customer indicated that they did not check the sample for the presence of bubbles.It was recommended that the customer enabling slope score on their instrument, which should reduce aberrant values due to sample preparation/quality issues.The ticket searches determined that there is no unusual activity for the likely cause lot 72324fn00.Complaint trending report review determined that there is no non-statistical or adverse trends related to the customer's issue for the architect cea assay.Since no patient sample was available to assist in the investigation, accuracy testing was performed using a cea serum based panel which mimics patient samples and is closest in concentration to the customers expected results.Accuracy testing was completed using an in-house retained kit stored at the recommended storage condition.All specifications were met indicating that the lot is performing acceptably.A review of the manufacturing documentation did not identify any issues associated with the customer observation.Labeling was reviewed and sufficiently addresses the customer's issue.Using world wide field data for the architect cea assay, the performance of reagent lot 72324fn00 was compared to the performance of all architect cea lots used in the field in the last twelve months.This review indicates that lot 72324fn00 is performing similar to other reagent lots in the field.No systemic issue or deficiency of the architect anti-hcv 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: 6645040
• Report Number: 3008344661-2017-00057
• Device Sequence Number: 13684520
• Product Code: DHX
• UDI-Device Identifier: 00380740014575
• UDI-Public: (01)00380740014575(17)180723(10)72324FN00
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 07/13/2017

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: 07/23/2018
• Device Catalogue Number: 07K68-27
• Device Lot Number: 72324FN00
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/07/2017
• Supplement Date Received by Manufacturer: Not provided; 07/07/2017
• Initial Report FDA Received Date: 06/15/2017
• Supplement Report FDA Received Date: 06/15/2017; 07/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR