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

Catalog Number	08837031190
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event occurred on a cobas e 601 analyzer (serial number: (b)(6)).The investigation determined that the anti-hcv ii assay performed within specifications.A review of calibration and quality control data confirmed that all results were within the expected ranges.The discrepancy was attributed to a false reactive result, which is covered by the assay's claimed specificity.The device remained in operation at the customer site.
Event or Problem Description
The initial reporter alleged discrepant positive results for one patient sample tested with the anti-hcv g2 elecsys cobas e 200 v2 assay on the cobas 6000 e601 module.The initial roche results were reactive with a value of 28 coi, obtained from two separate runs using two different samples.Testing of the same sample on the siemens attelica system yielded a negative result.No western blot result was available.Further investigation included testing the sample on a cobas e 602 module with the anti-hcv ii reagent, which produced a reactive result of 25.34 coi.Additional testing with the fujirebio innolia hcv score assay yielded a clear negative result.

• 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: 23100145
• Report Number: 1823260-2025-03285
• Device Sequence Number: 9224980
• Product Code: MZO
• UDI-Device Identifier: 07613336166970
• UDI-Public: 07613336166970
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2023
• Device Catalogue Number: 08837031190
• Device Lot Number: 652930
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/02/2023
• 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 Sex: Unknown