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

Catalog Number	07027079190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter questioned high results from 2 samples from 1 patient not corresponding to the clinical picture when tested for elecsys cea (cea) on a cobas e 801 analytical unit.Sample 1 result from the e801 unit was 19.8 ng/ml (normal reference range 0 ¿ 5 ng/ml).The sample was repeated on the same unit with a result of 20.7 ng/ml.The sample was repeated on a different e801 module with a result of 20 ng/ml.The result from the siemens method was 3.53 ng/ml (normal reference range 0 ¿ 10 ng/ml).On 28-jul-2022 sample 2 result from the e801 unit was 20.3 ng/ml (normal reference range 0 ¿ 5 ng/ml).The sample was repeated on a different e801 module with a result of 20.8 ng/ml.The result from the siemens method was 3.75 ng/ml (normal reference range 0 ¿ 10 ng/ml).The questionable results were reported outside of the laboratory.The patient had been treated after radical resection of esophageal squamous cell carcinoma with albumin paclitaxel and sintilimab for 4 cycles of treatment then sintilimab for 16 cycles of treatment.Based on the treatment received, the doctor thought the cea results should be within the normal range.The e801 unit serial number was (b)(4).The serial number for the other e801 module was not provided.
Additional Manufacturer Narrative
The samples were requested for investigation.
Additional Manufacturer Narrative
Section d4, lot number was updated.
Additional Manufacturer Narrative
Section d4, expiration date was updated.Qc results do not indicate an issue.Sample material was received for investigation and was tested on an e801 module with cea reagent lot: 607340.The customer's results were reproducible.The repeat results at the investigation site were 19.7 ng/ml and 20.2 ng/ml.The sample material underwent polyethylene glycol (peg) precipitation testing.The results from the investigation do not indicate an interference.The investigation did not identify a product problem.The cause of the event could not be determined.

• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15293886
• Report Number: 1823260-2022-02556
• Device Sequence Number: 17701558
• Product Code: DHX
• UDI-Device Identifier: 04015630939664
• UDI-Public: 04015630939664
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 10/20/2022

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: 06/30/2023
• Device Catalogue Number: 07027079190
• Device Lot Number: 607340
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2022
• Supplement Date Received by Manufacturer: 08/29/2022; 09/28/2022
• Initial Report FDA Received Date: 08/25/2022
• Supplement Report FDA Received Date: 09/19/2022; 10/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Age: 54 YR
• Patient Sex: Male