MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS ANTI-HCV II; HEPATITIS C ANTIBODY ASSAY

Catalog Number	08837058190
Medical Device Problem Codes	False Positive Result (1227); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with elecsys anti-hcv ii on a cobas e 801 analytical unit and an unknown roche analyzer.The sample was initially rested on the customer's e 801 analyzer, resulting in an anti-hcv value of 53 coi (reactive).The sample was sent to another laboratory for testing on an unknown device and it resulted in an anti-hcv value of 0.6 coi.The sample was repeated on the customer's e 801 anlayzer on (b)(6) 2025, resulting in an anti-hcv value of 59 coi (reactive).The sample was provided for investigation where it was tested on an unknown roche device on (b)(6) 2025, resulting in anti-hcv values of 62.3 coi (reactive) and 62.6 coi (reactive).During investigations, the sample was also tested using an unknown clia method, resulting in an anti-hcv value of 0.69 s/co (non-reactive).
Additional Manufacturer Narrative
The serial number of the e 801 analyzer is: (b)(6).The serial number of the other roche analyzer was requested, but not provided.The investigation is ongoing.
Additional Manufacturer Narrative
The patient sample was tested using the fujirebio hcv score method, and the result was indeterminate (1+ ns3 band).It cannot be determined which result is correct due to the indeterminate immunoblot result.False reactive results may occur in elecsys anti-hcv ii as the assay has a specificity of < 100%.For diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination, and other findings.The elecsys anti-hcv ii assay performs within specification.

• Brand Name: ELECSYS ANTI-HCV II
• Common Device Name: HEPATITIS C ANTIBODY ASSAY
• 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: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 23643673
• Report Number: 1823260-2025-04818
• Device Sequence Number: 15985740
• Product Code: MZO
• UDI-Device Identifier: 07613336166994
• UDI-Public: 07613336166994
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K221693
• 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): 12/16/2025

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: 07/31/2026
• Device Catalogue Number: 08837058190
• Device Lot Number: 86700401
• 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: 11/05/2025
• Supplement Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 12/16/2025
• 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