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 Negative Result (1225); False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable elecsys anti-hcv ii results with two patient samples tested on a cobas e 411 analyzer (rack system) compared to a competitor method.Sample 1 (b)(6) 2025): the initial result was 0.066 coi (non-reactive).The repeat result using the vidas system was reactive.The sample was repeated 5-6 times and the results were consistent each time.Sample 2 (b)(6) 2025): the initial result was 21.85 coi (reactive).The repeat result was 21.3 coi (reactive).The repeat result using the vidas system was non-reactive.
Additional Manufacturer Narrative
The serial number of the analyzer is (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
Qc and calibration were acceptable.Per the product labeling, "all initially reactive or borderline results giving coi = 0.9 or <1.0 should be rerun in duplicate using the elecsys anti-hcv ii assay.Confirm repeatedly reactive results (coi = 0.90) by independent confirmation methods/according to supplementary algorithms.Confirmatory tests include immunoblot and rna tests.If one or both measurements remain borderline the analysis of a follow-up sample is recommended.For diagnostic purposes, the results should always be assessed in conjunction with the patients' medical history, clinical examination and other findings." the anti-hcv ii assay performs within specification.The investigation determined that a sample specific issue is likely.

• 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: 23594551
• Report Number: 1823260-2025-04711
• Device Sequence Number: 9641055
• Product Code: MZO
• UDI-Device Identifier: 07613336166956
• UDI-Public: 07613336166956
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• 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,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: 11/30/2025
• Device Catalogue Number: 08836981190
• Device Lot Number: 845977
• 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: 10/29/2025
• Supplement Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 11/19/2025
• 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 Sex: Unknown