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

Catalog Number	11776193122
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	10/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the customer's cobas e411 rack is (b)(6).The field service engineer (fse) cleaned the gripper and performed a precision check which showed normal analyzer function.The investigation is ongoing.
Event or Problem Description
The initial reporter received a questionable ca 19-9 elecsys result from one patient sample tested on the cobas e411 rack.The initial result was 2.77 u/ml.The first repeat result was 51.01 u/ml.The second repeat result was 3.00 u/ml.The reporter stated that they expected the lower results.
Additional Manufacturer Narrative
The investigation reviewed the calibration data; the calibration signals started high but through time, the signals started falling steadily with each calibration being lower than the previous one.The investigation reviewed the qc data provided (23-oct-2023 for qc level 1 and 28-sep-2023 for qc level 2).The qc level 1 trace showed five results that were out of the -3 standard deviation (sd) range.The rest of the results were around the target value.The qc level 2 trace showed results around the target range.It was not possible to evaluate the qc accurately for the date of event as the customer only provided screenshots of the qc data.Based on the information provided, the cause of the event could not be determined.The provided data do not indicate a reagent issue.

• Brand Name: ELECSYS CA 19-9
• Common Device Name: TEST, CARBOHYDRATE ANTIGEN (CA19-9)
• 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: 18130974
• Report Number: 1823260-2023-03598
• Device Sequence Number: 7752723
• Product Code: NIG
• UDI-Device Identifier: 04015630904297
• UDI-Public: 04015630904297
• Combination Product (Y/N): Y
• Initial Reporter Country: SI
• 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): 12/15/2023

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 Catalogue Number: 11776193122
• Device Lot Number: 705691
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/20/2023
• Supplement Date Received by Manufacturer: 11/22/2023
• Initial Report FDA Received Date: 11/14/2023
• Supplement Report FDA Received Date: 12/15/2023
• 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