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 Codes	High Test Results (2457); Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received questionable ca 19-9 elecsys e2g results for one patient tested on a cobas 8000 e 801 module.It was requested but not provided if the initial ca 19-9 result was reported outside the laboratory.The customer performed dilution testing with the patient's sample due to the initial ca 19-9 result not matching the patient's previous result.The patient's initial undiluted ca 19-9 result was 431 u/ml.The patient's repeat ca 19-9 result with a 1:2 dilution was 569 u/ml.The patient's repeat ca 19-9 result with a 1:10 dilution was 905 u/ml.The e 801 module serial number was requested but not provided.
Additional Manufacturer Narrative
For dilution testing, product labeling states "samples with ca 19-9 concentrations above the measuring range can be diluted with diluent universal.The recommended dilution is 1:10 (either automatically by the analyzer or manually).The concentration of the diluted sample must be > 50 u/ml." also, "the ca 19-9 antigen tends to aggregate.This may lead to nonlinear dilution behavior in certain individual samples." the investigation is ongoing.
Additional Manufacturer Narrative
The patient's sample was tested on a lumipulse analyzer and had the following ca 19-9 results: the patient's undiluted ca 19-9 result was 1270 u/ml.The patient's ca 19-9 result with a 1:2 dilution was 1532 u/ml.The patient's ca 19-9 result with a 1:5 dilution was 1725 u/ml.The patient's ca 19-9 result with a 1:10 dilution was 1900 u/ml.The patient's ca 19-9 result with a 1:20 dilution was 1940 u/ml.The patient's ca 19-9 result with a 1:50 dilution was 1950 u/ml.The patient's ca 19-9 result with a 1:100 dilution was 2090 u/ml.The customer's calibration and qc results, sample pre-analytic details, and system alarm trace were requested but not provided.The investigation determined the patient's sample had false low elecsys ca 19-9 results and the dilution testing confirmed the non-linear dilution behavior.The investigation determined the ca 19-9 results with other methodologies confirmed the elecsys ca 19-9 were false low.Based on the provided information, the cause for the false low ca 19-9 results and the non-linear dilution behavior of the patient sample could not be established.For dilution testing, product labeling states, "samples with ca 19-9 concentrations above the measuring range can be diluted with diluent universal.The recommended dilution is 1:10 (either automatically by the analyzer or manually).The concentration of the diluted sample must be > 50 u/ml." also, "note: the ca 19-9 antigen tends to aggregate.This may lead to nonlinear dilution behavior in certain individual samples."note: the ca 19-9 antigen tends to aggregate.This may lead to nonlinear dilution behavior in certain individual samples." based on the provided information, a general reagent issue could be excluded.
Additional Manufacturer Narrative
The patient's sample was provided for an investigation and tested on an unknown roche analyzer.The patient's undiluted ca 19-9 result was 430 u/ml.The patient's ca 19-9 result with a 1:2 dilution was 609 u/ml.The patient's ca 19-9 result with a 1:5 dilution was 787 u/ml.The patient's ca 19-9 result with a 1:10 dilution was 918 u/ml.The patient's ca 19-9 result with a 1:20 dilution was 985 u/ml.The patient's ca 19-9 result with a 1:50 dilution was 1093 u/ml.The patient's ca 19-9 result with a 1:100 dilution was 1231 u/ml.The investigation is ongoing.

• 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: 13712724
• Report Number: 1823260-2022-00631
• Device Sequence Number: 17501194
• 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,Followup,Followup
• Report Date (Section B): 04/28/2022

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 Expiration Date: 08/31/2022
• Device Model Number: CA 19-9 ELECSYS E2G
• Device Catalogue Number: 07027028190
• Device Lot Number: 52551002
• 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: 02/14/2022
• Supplement Date Received by Manufacturer: 02/24/2022; 03/23/2022; 04/12/2022
• Initial Report FDA Received Date: 03/09/2022
• Supplement Report FDA Received Date: 03/19/2022; 04/14/2022; 04/28/2022
• 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: Male