MAUDE Adverse Event Report: BECKMAN COULTER ACCESS CEA; SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN

Catalog Number	33200
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer did not provide patient demographics such as age, date of birth, weight, ethnicity or race.The access cea reagent was not returned for evaluation.All assay and system verifications (calibration, quality control, system check) met specifications at the time of this event.No hardware errors, flags or other assay issues were reported in conjunction with this event.Conclusion: the cause of the elevated access cea result cannot be determined with the available information.
Event or Problem Description
The customer reported obtaining an elevated carcinoembryonic antigen (access cea) result for one patient involving the laboratory's access 2 immunoassay system portion to their unicel dxc 600i synchron access clinical system (serial number (b)(4)).The result was reported out of the laboratory.Due to the elevated result, the patient had a cat scan and a colonoscopy.The customer reported that the results were negative.There was no report of additional change to treatment.Approximately one month later another sample was collected from the patient and analyzed two times on the same access 2 immunoassay system portion to their unicel dxc 600i synchron access clinical system.This sample recovered with lower access cea results.Quality control (qc), calibration and system check were performing within assay and instrument specifications at the time of the event.There were no hardware errors or other assay issues reported in conjunction with this event.The samples were collected in serum tubes and centrifuged at 3150 revolutions per minute (rpm) for ten minutes at room temperature.No issues with sample integrity were reported.

• Brand Name: ACCESS CEA
• Common Device Name: SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN
• Manufacturer (Section D): BECKMAN COULTER; 1000 lake hazeltine drive; chaska MN 55318
• MDR Report Key: 7362004
• Report Number: 2122870-2018-00021
• Device Sequence Number: 1232994
• Product Code: DHX
• UDI-Device Identifier: 15099590624842
• UDI-Public: (01)15099590624842(17)181009(11)171009(10)795018
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K031270
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/09/2018
• Device Catalogue Number: 33200
• Device Lot Number: 795018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2018
• Initial Report FDA Received Date: 03/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other