MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS CA 19-9; CARBOHYDRATE ANTIGEN (CA19-9) TEST SYSTEM

Catalog Number	07027028190
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	07/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The e801 module serial number was (b)(6).The calibration was last performed on 11-jun-2024 and it was acceptable.The alarm trace showed multiple "detection of clots in the sample" and "foam detection in the sample" alarms indicating possible sample quality issues.The investigation is ongoing.
Event or Problem Description
We received an allegation about discrepant results for 1 patient serum/plasma sample tested with elecsys ca 19-9 assay on a cobas e801 immunoassay analyzer.Initial result: 723 u/ml.The patient questioned the initial result as it did not match a result that was obtained at a different laboratory.On (b)(6) 2024 the sample was then repeated and the repeat result was 11.8 u/ml.
Additional Manufacturer Narrative
The repeat result of 11.8 u/ml was considered correct.Qc was not within range before the second measurement.The provided data do not indicate a reagent issue.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS CA 19-9
• Common Device Name: CARBOHYDRATE ANTIGEN (CA19-9) 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: 20214518
• Report Number: 1823260-2024-02660
• Device Sequence Number: 15389908
• Product Code: NIG
• UDI-Device Identifier: 04015630939640
• UDI-Public: 04015630939640
• Combination Product (Y/N): Y
• Initial Reporter Country: BR
• PMA/510(K) Number: K050231
• 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): 10/14/2024

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: 03/31/2025
• Device Catalogue Number: 07027028190
• Device Lot Number: 736768
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/22/2024
• Supplement Date Received by Manufacturer: 10/04/2024
• Initial Report FDA Received Date: 09/13/2024
• Supplement Report FDA Received Date: 10/14/2024
• 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 Age: 39 YR
• Patient Sex: Male