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
Udi: (b)(4).Lot/serial number was manufactured prior to udi compliance date; therefore, only a di is provided.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer stated that the architect analyzer generated falsely decreased cea results on one patient.The results provided were: initial = 5.0 / repeat = 15,000.There was no reported impact to patient management.There was no additional patient information provided.
Additional Manufacturer Narrative
The customer observed a depressed cea result of <0.5ng/ml when using architect cea, list number 7k68-27, lot number 61610lf00 on their architect i2000sr analyser.The complaint text states that the customer agrees that it was a temporary incident and that poor sampling from air bubbles could have caused the depressed result.A review of complaints determined there are no trends for architect cea.No patient sample was available to assist in the investigation.A review of the manufacturing documentation did not identify any issues associated with the customer observation for lot 61610lf00.A review of labeling shows adequate information is provided to address discrepant results including sample integrity / sample handling issues.This includes inspection of all samples for bubbles and the removal of bubbles with an applicator stick prior to analysis.The architect system operations manual provides troubleshooting for falsely elevated results.Based on all available information and this investigation, the assay performed as intended and no product deficiency was identified.
Additional Manufacturer Narrative
The device evaluation was reassessed and concluded that a malfunction occurred, therefore the device was not performing as intended.

• 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: 6112905
• Report Number: 3008344661-2016-00073
• Device Sequence Number: 16436274
• Product Code: DHX
• UDI-Device Identifier: 00380740014575
• UDI-Public: 00380740014575
• 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): 04/21/2017

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: 09/08/2017
• Device Catalogue Number: 07K68-27
• Device Lot Number: 61610FN00
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/28/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 11/18/2016
• Supplement Report FDA Received Date: 12/21/2016; 04/21/2017
• 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, LIST # (B)(4); SERIAL # (B)(4)