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	10/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas 8000 e 801 module serial number is (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of a questionable elecsys anti-hcv ii result from the cobas 8000 e 801 module for one patient.The sample yields a repeated reactive result, but on another roche analyzer, it gives a negative result.The initial result was 1.16 coi (reactive).The second result was 1.17 coi (reactive).The third result was 1.16 coi (reactive).The result on another roche analyzer was 0.769 coi (non-reactive).
Additional Manufacturer Narrative
The investigation included a review of the data set provided by the customer: the calibration and qc results for the reported analyzer are within the specified ranges.The alarm trace and preanalytical data did not indicate any issues.The event's cause could not be determined based on the information provided.Product labeling states: "coi - >/= to 1.00.Result - reactive.Interpretation of results - antibodies to hcv detected retest procedure - presumptive hcv infection, follow cdc recommendations for supplemental testing." single false results (false reactive or false non-reactive) can occur and are covered by the sensitivity and specificity claim of the assay.The reagent is performing within specification based on the provided calibration and qcs for the reported analyzer.

• 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: 23402639
• Report Number: 1823260-2025-04375
• Device Sequence Number: 10047513
• Product Code: MZO
• UDI-Device Identifier: 07613336166994
• UDI-Public: 07613336166994
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• 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): 03/18/2026

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: 823050
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/06/2025
• Supplement Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 03/18/2026
• 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