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

Catalog Number	08837058190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the e 801 analyzer is (b)(6).The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received discrepant results for two samples collected from the same patient and tested with elecsys anti-hcv ii on a cobas e 801 analytical unit.The first sample from (b)(6) 2026 and the second sample from (b)(6) 2026 both had positive anti-hcv results when tested on the e 801 analyzer.Both samples were negative when tested with the siemens atellica method.The customer provided data for one patient sample tested on the e 801 analyzer twice on 02-(b)(6) 2026, resulting in values of 39.4 coi (reactive) and 39.4 coi (reactive).It was asked, but it is not known if these measurements were performed with one of the two patient samples or if they were measurements performed with a sample from a different patient.
Additional Manufacturer Narrative
Additional data from the complained patient was provided by the customer.On 22-sep-2025, the patient had an anti-hcv result of 0.46 index (negative) when tested with the siemens atellica method.On (b)(6) 2025, the patient had an anti-hcv result of 1.08 index (equivocal) when tested with the siemens atellica method.When this sample was tested with the roche anti-hcv method, the result was 118.00 coi (reactive).On (b)(6) 2025, the patient had an anti-hcv result of 1.35 index (equivocal) when tested with the siemens atellica method.When this sample was tested with the roche anti-hcv method, the result was 153.00 coi (reactive).When this sample was tested with the abbott rt-pcr method, hepatitis c rna result was non-detectable.On (b)(6) 2026, the patient had an anti-hcv result of 1.62 index (positive) when tested with the siemens atellica method.When this sample was tested with the roche anti-hcv method, the result was 198.00 coi (reactive).When this sample was tested with the abbott rt-pcr method, hepatitis c rna result was non-detectable.Calibration and control data were acceptable.Alarm trace data did not show any abnormalities.All initially reactive or borderline samples should be retested in duplicate using the elecsys anti-hcv ii assay.Repeatedly reactive samples are to be confirmed via supplemental methods (e.G.Immunoblot or detection of hcv rna).Results are only rated as positive after duplicate retest and confirmation testing.Single false positive results can occur based on the labeled specificity claim.A general reagent issue can be excluded, the reagent performed within specification.
Additional Manufacturer Narrative
It was clarified that the second sample from the patient was tested on (b)(6) 2026, not on (b)(6) 2026.The customer provided data for two additional patient samples (samples 3 and 4).It is not known if this data was from the same samples reported previously or if these are new patient samples.Sample 3 was tested on the e 801 on (b)(6) 2025, resulting in an anti-hcv value of 118 coi (reactive).The sample resulted in a value of 1.08 (non-reactive) with the siemens atellica method.Sample 4 was tested on the e 801 on (b)(6) 2025, resulting in an anti-hcv value of 153 coi (reactive).The sample resulted in a value of 1.35 (non-reactive) with the siemens atellica method.The units of measure used for the siemens atellica method were not provided.Medwatch fields b3 date of event and d4, expiration date, have been updated.

• 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: 24333412
• Report Number: 1823260-2026-00512
• Device Sequence Number: 13207086
• Product Code: MZO
• UDI-Device Identifier: 07613336166994
• UDI-Public: 07613336166994
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Followup
• Report Date (Section B): 03/30/2026

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: 906652
• 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: 01/23/2026
• Supplement Date Received by Manufacturer: 02/09/2026; 03/16/2026
• Initial Report FDA Received Date: 02/13/2026
• Supplement Report FDA Received Date: 02/27/2026; 03/30/2026
• 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