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	02/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the e 402 instrument is (b)(6).The field service engineer checked the volume in the wash wells, checked the pump pressures, and adjusted probes.The sample line was calibrated.The instrument performed well after these actions.Of the provided quality control data, one level of control performed on (b)(6) 2024 was within range.Upon review of the alarm trace, no relevant alarms were observed.The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with elecsys ca 19-9 on a cobas pure e 402 analytical unit.The sample initially resulted in a ca 19-9 value of 144 u/ml.The sample was repeated on (b)(6) 2024, resulting in a ca 19-9 value of 8.94 u/ml.The sample was also repeated three times on a second cobas instrument in the laboratory on (b)(6) 2024, resulting in ca 19-9 values of 9.14 u/ml, 9.25 u/ml, and 9.16 u/ml.The sample was also repeated on a competitor instrument and the lower value was confirmed.No specific data was provided from this instrument.
Additional Manufacturer Narrative
The field service engineer performed multiple actions, including cleaning the water tank, replacing pinch tubing and probes, and modifying the gear pump head.Precision studies were performed and were acceptable.Isolated non-reproducible results do not represent a general malfunction of the assay.The investigation could 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: 18864798
• Report Number: 1823260-2024-00703
• Device Sequence Number: 3491708
• Product Code: NIG
• UDI-Device Identifier: 04015630939640
• UDI-Public: 04015630939640
• Combination Product (Y/N): Y
• Initial Reporter Country: IT
• 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): 03/29/2024

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: 73676801
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/26/2024
• Supplement Date Received by Manufacturer: 03/28/2024
• Initial Report FDA Received Date: 03/08/2024
• Supplement Report FDA Received Date: 03/29/2024
• 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