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

Catalog Number	07026889190
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the e 801 analyzer is (b)(6).An aliquot of the proficiency sample was provided for investigation and immunoblot analysis of the sample confirmed a false reactive result in the elecsys anti-hcv assay.During investigation, the sample measured using the elecsys anti-hcv assay on recovered values of 1.02 coi (reactive) and 1.11 coi (reactive), which are near the cutoff of the assay (cutoff = 1.00 coi).Single false positive results can occur due to unspecific interferences and are covered by the claimed specificity of the assay.The proficiency survey sample might be processed or altered with additives which might lead to unspecific interferences.For samples close to cut-off, only a slight influence of unspecific interference can lead to discrepant results.
Event or Problem Description
The initial reporter stated they received a questionable result for one proficiency survey sample tested with elecsys anti-hcv ii on a cobas e 801 module.Proficiency material is not used for diagnostic purposes.The expected anti-hcv result for the sample was non-reactive/negative.When the customer tested the sample on the e 801 analyzer, the result was 1.27 coi (reactive).This medwatch is being submitted in an abundance of caution.
Additional Manufacturer Narrative
Medwatch field h6, component code has been updated.

• 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: 22786763
• Report Number: 1823260-2025-02460
• Device Sequence Number: 8256663
• Product Code: MZO
• UDI-Device Identifier: 04015630939947
• UDI-Public: 04015630939947
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: P140021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2025

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 Expiration Date: 01/31/2023
• Device Catalogue Number: 07026889190
• Device Lot Number: 58790601
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/05/2022
• Supplement Date Received by Manufacturer: 08/14/2025
• Initial Report FDA Received Date: 08/12/2025
• Supplement Report FDA Received Date: 09/03/2025
• 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