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

Catalog Number	08836981190
Medical Device Problem Codes	False Positive Result (1227); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
"the initial reporter alleged discrepant reactive results for one patient sample tested using the anti-hcv g2 elecsys cobas e 100 v2 assay on the cobas 6000 e601 module.In (b)(6) 2023, the patient sample was tested using the elecsys ahcv ii assay and generated a reactive result of 2 coi.A re-run of the same sample confirmed the initial reactive result.Testing of the same patient sample at a different laboratory using the abbott ahcv assay produced a non-reactive result (date not provided).Subsequent testing of the patient sample using the elecsys ahcv ii assay again generated a reactive result (date not provided).".
Additional Manufacturer Narrative
The reported event occurred on a cobas e 601 analyzer (serial number: (b)(6)).The investigation determined that the elecsys ahcv ii assay performed within specifications.A review of calibration and quality control data confirmed that all results were within expected ranges.No additional information or feedback was received from the affiliate to clarify the testing details or patient history.The investigation was limited by the unavailability of confirmatory testing results, such as immunoblot or hcv-rna, and the lack of responses to follow-up inquiries.The root cause of the reported discrepant results could not be determined based on the available information.The case was closed with a recommendation to confirm repeatedly reactive patient sample results using supplemental methods, such as immunoblot or hcv-rna detection, and to assess results in conjunction with the patient¿s medical history, clinical examination, and other findings.

• 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: 23100335
• Report Number: 1823260-2025-03288
• Device Sequence Number: 12953264
• Product Code: MZO
• UDI-Device Identifier: 07613336166956
• UDI-Public: 07613336166956
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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: 07/31/2024
• Device Catalogue Number: 08836981190
• Device Lot Number: 74817702
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/11/2024
• 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