MAUDE Adverse Event Report: Roche Diagnostics Elecsys Anti-HCV II; Hepatitis C Antibody Assay

Catalog Number	08837058190
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the customer's e 801 analyzer is (b)(6).\ \ the serial number of the e 801 analyzer used for investigation is (b)(6).\ \ single false reactive results can occur based on the labeled specificity claim of the assay.\ \ for repeatedly reactive samples, cdc recommendations for supplemental testing must be followed.\ \ for diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings.\ \ the investigation is ongoing.
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with elecsys anti-hcv ii on\t\ two cobas e 801 analytical units.\ \ the sample was tested twice on the customer's e 801 analyzer, resulting in anti-hcv values of 26.4 coi (reactive) and 26.5 coi (reactive).\ \ the sample was provided for investigation, where it was tested twice on a second e 801 analyzer on 10-sep-2026, resulting in anti-hcv values of 26.0 coi (reactive) and 26.1 coi (reactive).\ \ during investigations, the sample was tested with an unknown clia assay method, resulting in an anti-hcv value of 0.67 (negative).No units of measure were provided.\ \ during investigations, the sample was also tested with the fujirebio hcv score method, resulting in the following values:\ c1 antigen = negative.\ c2 antigen = negative.\ e2 antigen = negative.\ ns3 antigen = \"+/-\".\ ns4 antigen = negative.\ ns5 antigen = negative.\ final result = inconclusive.

• Brand Name: Elecsys Anti-HCV II
• Common Device Name: Hepatitis C Antibody Assay
• Manufacturer (Section D): Roche Diagnostics; 9115 hague road; indianapolis IN 46250 -045
• 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: 50913429
• Report Number: 1823260-2026-03969
• Device Sequence Number: 5393494
• 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
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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 Catalogue Number: 08837058190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/11/2026
• Initial Report FDA Received Date: 09/28/2026
• 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