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

Catalog Number	11776193122
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).The samples were requested for investigation.The investigation is ongoing.
Event or Problem Description
There was an allegation of a suspected interference with the elecsys ca 19-9 assay on a cobas 8000 e 602 module.In 2020, the patient's result was 16.11 u/ml.The specific date was not provided.On (b)(6) 2024, the patient's result was 365.4 u/ml and the repeated result was 360.9 u/ml on the e 602 module.On (b)(6) 2024, the patient's result was 14.33 u/ml with another method (mindray cl6000i).On (b)(6) 2024, the patient's sample from (b)(6) 2024 was retested on the e602 module and the results were 334.9 u/ml and 358.2 u/ml.On (b)(6) 2024, the patient's result was 14 u/ml with another method (snibe maglumi x8).This sample was also sent to be tested on other instruments and the results were: the result using a cobas e801 module was 364 u/ml.The result using abbott alinity was >1200 u/ml.The result using beckman dxi800 was 10.8 u/ml.The result using wantai was 14.93 u/ml.On (b)(6) 2024, the patient's result was 308.9 u/ml on the e 602 module.
Additional Manufacturer Narrative
The customer did a peg-precipitation and a serial dilution experiment.The peg-precipitation showed a poor recovery for this patient sample which can be an indication for a presence of interfering substance(s).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.For diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings." the product performed within the specified limit.

• 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: 19120040
• Report Number: 1823260-2024-01185
• Device Sequence Number: 20922679
• Product Code: NIG
• UDI-Device Identifier: 04015630904297
• UDI-Public: 04015630904297
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• 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): 05/08/2024

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: 09/30/2024
• Device Catalogue Number: 11776193122
• Device Lot Number: 70569105
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/22/2024
• Supplement Date Received by Manufacturer: 04/18/2024
• Initial Report FDA Received Date: 04/16/2024
• Supplement Report FDA Received Date: 05/08/2024
• 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 Age: 44 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian