MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS CEA; CARCINOEMBRYONIC ANTIGEN TEST SYSTEM

Catalog Number	07027079190
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The e801 module serial number is (b)(6).
Event or Problem Description
The initial reporter complained of a discrepant high result for 1 patient sample tested for elecsys cea (cea) on a cobas e 801 msb/msbl.The initial result was 11.8 ng/l.The repeat result was <0.3 ng/l.On (b)(6) 2025 the repeat result was <0.3 ng/l.The initial result did not correspond to the patient¿s clinical condition and the sample was repeated.The questionable result was not reported outside of the laboratory.
Additional Manufacturer Narrative
Calibration was last performed on 12-sep-2024 with acceptable results.Qc was acceptable before the event.Four "sample clot detection" and one "sample foam detection" alarm were observed on the alarm trace data from (b)(6) 2024.During a review of the sample foam detection images, dirt was observed on the gripper.Based on the information provided, the cause of the event could not be determined.The investigation did not identify a product problem.

• Brand Name: ELECSYS CEA
• Common Device Name: CARCINOEMBRYONIC ANTIGEN TEST SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 20494941
• Report Number: 1823260-2024-03031
• Device Sequence Number: 3615833
• Product Code: DHX
• UDI-Device Identifier: 04015630939664
• UDI-Public: 04015630939664
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• PMA/510(K) Number: K980887
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2024

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: 10/31/2025
• Device Catalogue Number: 07027079190
• Device Lot Number: 801176
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/26/2024
• Supplement Date Received by Manufacturer: 10/22/2024
• Initial Report FDA Received Date: 10/21/2024
• Supplement Report FDA Received Date: 11/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown