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

Catalog Number	08837031190
Medical Device Problem Codes	False Positive Result (1227); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable elecsys anti-hcv ii results for 1 patient sample on a cobas e 801 analytical unit compared to two competitor analyzers.The customer questioned the initial result as it did not match the patient's clinical history.The e801 analyzer result was 2.19 coi and the repeat result was 2.38 coi, both interpreted as reactive.The yhlo analyzer result was 0.17 coi, interpreted as non-reactive.The abbott analyzer result was 0.13 s/co.The yhlo analyzer result was deemed correct.No questionable results were reported outside of the laboratory.
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).The calibration and qc recovery data provided was acceptable.The investigation is ongoing.
Additional Manufacturer Narrative
Calibration was last performed on (b)(6) 2025 and was acceptable.A sample-specific discrepancy is likely.The specificity of elecsys ahcvii is less than 100%.All initially reactive samples (results = 0.9 coi) should be re-determined in duplicate with the elecsys anti-hcv ii assay.For repeatedly reactive samples, confirmation via supplemental methods (e.G.Immunoblot or detection of hcv rna) is recommended.For diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings.The investigation did not identify a product problem.

• 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: 23416582
• Report Number: 1823260-2025-04409
• Device Sequence Number: 10431823
• Product Code: MZO
• UDI-Device Identifier: 07613336166970
• UDI-Public: 07613336166970
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 11/24/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 08837031190
• Device Lot Number: 846034
• 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: 10/09/2025
• Supplement Date Received by Manufacturer: 11/03/2025
• Initial Report FDA Received Date: 10/29/2025
• Supplement Report FDA Received Date: 11/24/2025
• 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 Sex: Unknown