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

Model Number	CA 19-9
Medical Device Problem Codes	Incorrect Measurement (1383); High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable elecsys ca 19-9 immunoassay results for 1 patient sample on a cobas e 411 immunoassay analyzer.The initial ca 19-9 result was > 1000 u/ml.A 1:5 dilution was made with the patient sample and the result was 242.2 u/ml.The sample was run undiluted again and the result was > 1000 u/ml.A 1:2 dilution was then made with the patient sample and the result was 481.4 u/ml.The sample was recentrifuged and run undiluted again and the result was > 1000 u/ml.No questionable results were reported outside of the laboratory.The reagent lot number is 598103.The expiration date was requested but not provided.
Additional Manufacturer Narrative
The patient is diagnosed with asthma.The investigation confirmed the customer's dilution results.Three-hour neuraminidase treatment was performed on the patient sample and it showed incomplete degradation.Protein a addition treatment was performed and the result showed 1.5% recovery.Neuraminidase treatment was also performed on a competitor analyzer and the result showed complete degradation.The investigation determined that the root cause of the discrepant dilution results is consistent with sample interference.Product labeling states, "in rare cases, interference due to extremely high titers of antibodies to analyte-specific antibodies, streptavidin or ruthenium can occur.These effects are minimized by suitable test design." the investigation did not identify a product problem.Based on the available data, a general reagent issue could be excluded.

• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15836483
• Report Number: 1823260-2022-03713
• Device Sequence Number: 20190260
• Product Code: NIG
• UDI-Device Identifier: 04015630904297
• UDI-Public: 04015630904297
• 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): N
• 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): 12/20/2022
• 2 Devices were Involved in the Event: 1 2

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
• Device Catalogue Number: 11776193122
• Device Lot Number: 598103
• 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: 10/29/2022
• Supplement Date Received by Manufacturer: 12/01/2022
• Initial Report FDA Received Date: 11/21/2022
• Supplement Report FDA Received Date: 12/20/2022
• 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