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	11/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analysis was performed on a cobas e 801 analytical unit with a serial number of (b)(6).The investigation determined that the anti-hcv g2 elecsys e2g 300 assay performed within specifications.Calibration and quality control data were reviewed and found to be within the expected ranges.No instrument-related issues were identified during the time of the reported event.The reported false positive result is consistent with the assay's specificity claim.Single false positive results can occur and are addressed in the product's method sheet, which recommends duplicate retesting and confirmation testing for initially reactive or borderline samples.Results are only considered positive after confirmation testing.A general reagent issue was excluded, and the reagent was confirmed to be performing as intended.
Event or Problem Description
The initial reporter alleged a possible false positive result with the anti-hcv g2 elecsys e2g 300 assay on the cobas e 801 analytical unit for one patient sample.On (b)(6) 2024, the elecsys anti-hcv ii assay generated a result of 53.1 coi (positive) on the cobas e 801 analytical unit.Testing of the same sample using a gold label method produced a negative result.Testing at another laboratory on the same date yielded a result of 47.1 coi (positive) with the elecsys anti-hcv ii assay on a cobas e 801 analytical unit, while testing with the abbott assay produced a result of 0.99 (negative).No original data were provided for the abbott or gold label methods.On (b)(6) 2024, polymerase chain reaction (pcr) testing of the sample produced a 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: 23099314
• Report Number: 1823260-2025-03251
• Device Sequence Number: 8572804
• Product Code: MZO
• UDI-Device Identifier: 04015630939947
• UDI-Public: 04015630939947
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: 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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2025
• Device Catalogue Number: 07026889190
• Device Lot Number: 76727501
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/11/2024
• 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