MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CA 19-9 ELECSYS E2G; CARBOHYDRATE ANTIGEN (CA19-9) TEST SYSTEM

Model Number	CA 19-9 ELECSYS E2G
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received questionable results for 9 patient samples tested with the elecsys ca 19-9 immunoassay.No incorrect results were reported outside of the laboratory.Refer to the attachment for all patient data.For the first five patient samples, the results measured after automatic dilution did not agree when tested on the cobas 8000 e 801 module.For samples 6 through 9, the ca 19-9 results measured on the e 801 analyzer did not agree with measurements performed on the cobas 8000 e 602 module.The serial number of the e 801 analyzer is (b)(4).The serial number of the e 602 analyzer was requested, but not provided.
Additional Manufacturer Narrative
Na.
Additional Manufacturer Narrative
Calibration and control data showed no issues.It was determined the customer did not use secondary cups required for use on the system.After using the recommended cups, the reproducibility of diluted sample results was much better.Per product labeling, the following sample cups are required for use: "hitachi standard cup 2.5 ml or cobas sample cup 2.5 ml".

• Brand Name: CA 19-9 ELECSYS E2G
• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 13205704
• Report Number: 1823260-2022-00079
• Device Sequence Number: 4564394
• Product Code: NIG
• UDI-Device Identifier: 04015630939640
• UDI-Public: 04015630939640
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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): 02/14/2022

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 Model Number: CA 19-9 ELECSYS E2G
• Device Catalogue Number: 07027028190
• Device Lot Number: 5255100
• 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: 12/15/2021
• Supplement Date Received by Manufacturer: 01/21/2022
• Initial Report FDA Received Date: 01/10/2022
• Supplement Report FDA Received Date: 02/14/2022
• 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 Sex: Unknown