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

Catalog Number	07027079190
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation about questionable results not matching the patient's clinical picture for 1 patient serum sample tested with elecsys cea assay, elecsys cyfra 21-1 assay, and elecsys he4 assay on a cobas 8000 cobas e602 module when compared to a non-roche analyzer.This medwatch will apply to the cea assay.Please refer to the medwatch with a1.Patient identifier pt (b)(6) for information related to the cyfra 21-1 assay.Please refer to the medwatch with a1.Patient identifier pt (b)(6) for information related to the he4 assay.The sample was initially tested on the e602 analyzer and repeated on a non-roche analyzer on (b)(6) 2024.Two test results were consistent.Cea: initial result: 13.62 ng/ml.Repeat result: 13.37 ng/ml.Cyfra 21-1: initial result: 54.37 ng/ml.Repeat result: 55.767 ng/ml.He4: initial result: 1500 pmol/l (accompanied by a data flag).Result after dilution: 1967.4 pmol/l.Repeat result: 1500 pmol/l (accompanied by a data flag).Result after dilution: 4151.754 pmol/l.The above patient test results were considered higher than the normal reference range.The customer suspected an interference.
Additional Manufacturer Narrative
The cyfra 21-1 reagent lot number was 711310 with an expiration date of 30-nov-2024.The he4 reagent lot number was 738510 with an expiration date of 31-mar-2025.The cobas 8000 core unit serial number was (b)(6).The alarm trace showed multiple abnormal sample aspiration alarms and abnormal sample probe movement alarms on the day of the event.The investigation is ongoing.
Additional Manufacturer Narrative
On (b)(6) 2024, the he4 result was 98.37 pmol/l after a manual dilution of 1:20 using diluent universal.The customer used an incorrect dilution solution for the he4 assay.The customer was advised to use diluent multiassay as the product labeling states: "samples with he4 concentrations above the measuring range can be diluted with diluent multiassay." on 19-jul-2024 the sample was requested but it was not available for investigation.Calibration and qc data were requested but were not provided.The investigation did not identify a product problem.The cea, cyfra 21-1, and he4 reagents perform within the specified ranges.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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 19730337
• Report Number: 1823260-2024-02003
• Device Sequence Number: 8206364
• 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): 08/09/2024

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: 01/31/2025
• Device Catalogue Number: 07027079190
• Device Lot Number: 749425
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/18/2024
• Supplement Date Received by Manufacturer: 07/16/2024
• Initial Report FDA Received Date: 07/12/2024
• Supplement Report FDA Received Date: 08/09/2024
• 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