MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS ANTI-HCV II; ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS

Catalog Number	08836981190
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter alleged a possible false positive anti-hcv result for a patient sample tested with the anti-hcv g2 elecsys cobas e 100 v2 assay on the cobas 6000 e601 module.On (b)(6) 2025, the sample was tested for anti-hcv and yielded a result of 34.82 coi (reactive).A re-examination of the primary sample on the same day produced a result of 34.66 coi (reactive).On (b)(6) 2025, a new blood sample was tested for anti-hcv and hcv rna.The anti-hcv result was 31.29 coi (reactive).A repeat test using ultracentrifugation at 10,000 rpm yielded a result of 30.85 coi (reactive).Hcv rna testing on the gen expert analyzer showed that hcv rna was not detected.Confirmation testing was performed using the abbott analyzer for anti-hcv, which produced a non-reactive result, and the cobas 6800 system for hcv rna, which also showed that hcv rna was not detected.
Additional Manufacturer Narrative
The anti-hcv ii reagent expiration date was not provided.The analysis was performed on a cobas 6000 e601 module (serial number: (b)(6)).The investigation determined that the anti-hcv g2 elecsys assay performed within specifications.A general reagent issue was excluded.False positive results are covered by the assay's specificity claim.The method sheet recommends confirmation testing for anti-hcv results, and the customer followed these recommendations.Confirmation testing with an alternative analyzer produced a non-reactive result, and hcv rna testing showed that hcv rna was not detected.The root cause was attributed to a single false positive result, which is consistent with the assay's performance characteristics.

• Brand Name: ELECSYS ANTI-HCV II
• Common Device Name: ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS
• 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: 23098329
• Report Number: 1823260-2025-03229
• Device Sequence Number: 12915928
• Product Code: MZO
• UDI-Device Identifier: 07613336166956
• UDI-Public: 07613336166956
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• 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
• Report Date (Section B): 09/19/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 08836981190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/25/2025
• Initial Report FDA Received Date: 09/19/2025
• 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 Age: 34 YR
• Patient Sex: Female