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

Model Number	CA 19-9 ELECSYS E2G
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer serial numbers are (b)(6).Clarification on which results came from which analyzer was not provided.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable elecsys ca 19-9 immunoassay results for 1 patient on a cobas e 801 analytical unit.The patient sample was tested twice and gave an undiluted ca 19-9 result of 1500 u/ml and 10 fold dilution result of 1500 u/ml.A second patient sample was collected the same day.The second patient sample was tested twice again and gave an undiluted ca 19-9 result of 340 u/ml and 10 fold dilution result of 340 u/ml.
Additional Manufacturer Narrative
The patient sample was not available for investigation.Based on the available data, a general reagent issue could be excluded.The root 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 17373469
• Report Number: 1823260-2023-02398
• Device Sequence Number: 7061076
• Product Code: NIG
• UDI-Device Identifier: 04015630939640
• UDI-Public: 04015630939640
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 09/01/2023

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 Model Number: CA 19-9 ELECSYS E2G
• Device Catalogue Number: 07027028190
• Device Lot Number: 66282100
• 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: 06/29/2023
• Supplement Date Received by Manufacturer: 08/16/2023
• Initial Report FDA Received Date: 07/21/2023
• Supplement Report FDA Received Date: 09/01/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: STOMACH MEDICATION
• Patient Sex: Unknown