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

Catalog Number	08836981190
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event involved a cobas 6000 e601 module (serial number: (b)(6).The investigation determined that a definitive root cause for the reported event could not be established due to the unavailability of the patient sample for further analysis.A general reagent issue was excluded based on the available data.A review of quality control data indicated that no quality control tests were performed on the day of the reported measurement (21-feb-2025).The last quality control performed on 18-feb-2025 was within the expected range.Calibration data from 24-feb-2025 showed no significant abnormalities, although some calibration data points were missing on the screen.The customer was advised to perform quality control testing prior to patient sample measurements and to conduct confirmatory testing as recommended in the method sheet.Monitoring the patient¿s clinical history and overall, health status was also recommended.
Event or Problem Description
The initial reporter alleged a possible false negative anti-hcv g2 elecsys cobas e 100 v2 result for a patient sample tested on the cobas 6000 e601 module.On (b)(6) 2025, the sample was tested on the cobas 6000 e601 module and generated a negative result of (b)(4) coi.The sample was retested the following day on the same instrument and again generated a negative result of (b)(4) coi.The sample was also tested on a cobas e 411 analyzer using a different reagent lot and generated a negative result.However, when the same sample was tested on a competitor instrument, vidas (enzyme-linked fluorescent assay [elfa] method), the result was positive.The patient reportedly had a previous positive anti-hcv result in 2017 using the elecsys anti-hcv assay.

• 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: 23070667
• Report Number: 1823260-2025-02968
• Device Sequence Number: 15951627
• Product Code: MZO
• UDI-Device Identifier: 07613336166956
• UDI-Public: 07613336166956
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 09/17/2025

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: 04/30/2025
• Device Catalogue Number: 08836981190
• Device Lot Number: 80491605
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/11/2025
• Initial Report FDA Received Date: 09/17/2025
• 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