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); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer's serial number is (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable reactive elecsys anti-hcv ii results for 1 patient on a cobas e 801 analytical unit.Sample 1: the elecsys anti-hcv result was 8.37 coi (reactive).On (b)(6) 2026, the sample was repeated, and the result was 8.94 coi (reactive).The sample was tested at another facility using the chemiluminescence methodology, and the result was 0.19 coi (non-reactive).This result was believed to be correct.Sample 2: on (b)(6) 2026, the elecsys anti-hcv result was 8.64 coi (reactive).On (b)(6) 2026, the sample was repeated, and the result was 8.31 coi (reactive).The sample was tested at another facility using the electrochemiluminescence methodology, and the result was 0.18 coi (non-reactive).This result was believed to be correct.
Additional Manufacturer Narrative
The qc and calibration were acceptable.A sample-specific discrepancy could not be excluded.The specificity of the elecsys anti-hcv ii assay is <100%.Repeatedly reactive samples must be confirmed according to recommended confirmatory algorithms.Confirmatory tests include immunoblot and rna tests.For diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings.Without confirmatory testing, further investigation could not be performed.The elecsys anti-hcv ii assay performs within specification.

• 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: 24493694
• Report Number: 1823260-2026-00744
• Device Sequence Number: 10684754
• Product Code: MZO
• UDI-Device Identifier: 07613336166994
• UDI-Public: 07613336166994
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 04/02/2026

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 Expiration Date: 07/31/2026
• Device Catalogue Number: 08837058190
• Device Lot Number: 86700401
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/05/2026
• Supplement Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 04/02/2026
• 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: 60 YR
• Patient Sex: Female