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	09/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the customer's cobas e 801 analytical unit is (b)(6).The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable elecsys cea assay results from one patient sample tested on the cobas e 801 analytical unit.The initial result from the analyzer was 4.22 ng/ml (positive).The repeat result of the recentrifuged patient sample from the analyzer was 4.26 ng/ml (positive).The patient sample was sent to another laboratory.The repeat result from a siemens analyzer (chemiluminescence laboratory method) was 1.58 ng/ml (negative).The repeat result from a beckman analyzer (unknown laboratory method) was also negative.
Additional Manufacturer Narrative
The investigation reviewed the calibration and qc data; the results were within specifications.The investigation reviewed the customer's handling of patient samples.The patient sample was centrifuged for 5 minutes which may be insufficient.A general reagent problem was not confirmed.The investigation did not identify a product problem.Product labeling states "please note - the measured cea value of a patient¿s sample can vary depending on the testing procedure used.The laboratory finding must therefore always contain a statement on the cea assay method used.Cea values determined on patient samples by different testing procedures cannot be directly compared with one another and could be the cause of erroneous medical interpretation.".

• 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: 20312291
• Report Number: 1823260-2024-02792
• Device Sequence Number: 18338724
• Product Code: DHX
• UDI-Device Identifier: 04015630939664
• UDI-Public: 04015630939664
• Combination Product (Y/N): Y
• Initial Reporter Country: IT
• 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): 11/01/2024

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): Initial
• Initial Date Received by Manufacturer: 09/03/2024
• Supplement Date Received by Manufacturer: 10/15/2024
• Initial Report FDA Received Date: 09/26/2024
• Supplement Report FDA Received Date: 11/01/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: STATINS
• Patient Sex: Unknown