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

Catalog Number	07026889190
Medical Device Problem Codes	False Positive Result (1227); High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with elecsys anti-hcv ii on a cobas e 801 analytical unit.The customer stated that the patient sample initially resulted in an anti-hcv value of 3 coi (reactive) and it repeated as 3 coi (reactive).Specific raw data was provided for an anti-hcv value of 3.4 coi (reactive).The sample was repeated using the abbott anti-hcv method on (b)(6) 2025, resulting in a value of 0.11 s/co (non-reactive).
Additional Manufacturer Narrative
The serial number of the e 801 analyzer is (b)(6).Calibration data from (b)(6) 2025 was within expected ranges.The investigation is ongoing.
Additional Manufacturer Narrative
Calibration data provided from after the event was within expected ranges.Quality controls were within expected ranges.A review of alarm trace data showed no relevant alarms.Instrument checks were acceptable.False reactive results may occur in elecsys anti-hcv ii, as the labeled assay specificity is < 100%.All initially reactive or borderline samples should be retested in duplicate using the elecsys anti-hcv ii assay.Confirmation is via supplemental methods.If one or both measurements remain borderline the analysis of a follow-up sample is recommended.Or diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings.The elecsys anti-hcv ii assay performs within specification.

• 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: 23568399
• Report Number: 1823260-2025-04662
• Device Sequence Number: 10128893
• Product Code: MZO
• UDI-Device Identifier: 04015630939947
• UDI-Public: 04015630939947
• Combination Product (Y/N): N
• Initial Reporter Country: GT
• 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,Followup
• Report Date (Section B): 12/18/2025

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: 01/31/2026
• Device Catalogue Number: 07026889190
• Device Lot Number: 823050
• 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: 10/28/2025
• Supplement Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 11/17/2025
• Supplement Report FDA Received Date: 12/18/2025
• 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 Age: 30 YR
• Patient Sex: Male