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	03/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation about discrepant results for 1 patient sample tested with elecsys anti-hcv ii assay at a "transferred" hospital.The patient was initially tested at the customer's site using abbott and siemens, both resulting in anti-hcv values of 0.1 coi (negative).The patient was transferred to a different hospital, and the sample was tested using the elecsys anti-hcv ii assay on an unknown analyzer, resulting in a value of 9.61coi (positive).The patient was then returned to the customer's site, where the following tests took place: the original sample was repeated, and the repeat result was negative.A new sample was drawn and tested, and the result was negative.Hcv-rna (nucleic acid test) was performed, and the result was not detected (negative).
Additional Manufacturer Narrative
The anti-hcv ii reagent expiration date was not provided.Per the labeled specificity and sensitivity claim of the assay: "false positive results due to non-specific reactivity cannot be ruled out with the elecsys anti-hcv ii assay." the product labeling states: "in rare cases, interference due to extremely high titers of antibodies to streptavidin or ruthenium can occur.These effects are minimized by suitable test design.Results obtained with the elecsys anti-hcv ii assay may not be used interchangeably with values obtained with different manufacturers¿ assay methods.For diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings." the product labeling also states: "elecsys ahcv ii results = 1.0 coi: result: reactive interpretation of results: antibodies to hcv detected.Retest procedure: presumptive hcv infection, follow cdc recommendations for supplemental testing." the investigation did not identify a product problem.The elecsys ahcv ii assay performs within specifications.

• 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: 24753294
• Report Number: 1823260-2026-01190
• Device Sequence Number: 18724812
• 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
• Report Date (Section B): 04/01/2026

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 04/01/2026
• 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 Age: 80 YR
• Patient Sex: Unknown