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); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas e411 rack analyzer serial number was (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable results for two patients from the cobas e411 rack analyzer.The customer could not provide the specific date of the event.An estimation of the "end of (b)(6)" was provided.This medwatch is for the elecsys anti-hcv ii assay.Refer to the medwatch with a1-patient identifier: (b)(6) for the elecsys hiv combi pt assay.The customer obtained positive results for both samples using a competitor's tests.The samples were then tested on the cobas e411 analyzer.Example 1 elecsys anti-hcv ii result was negative.The sample was then positive when tested using pcr.Example 2 elecsys hiv combi pt result was negative.The result from the "aids center" was negative.
Additional Manufacturer Narrative
The investigation was unable to determine a specific root cause.As no sample material was available, further investigation was not possible.The results are consistent with the sample being truly positive.As pcr is more sensitive, the discrepancy could arise from the fact that the sample was taken during seroconversion.There was no indication of a device malfunction.

• 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: 23827635
• Report Number: 1823260-2025-05155
• Device Sequence Number: 9277895
• Product Code: MZO
• UDI-Device Identifier: 07613336166956
• UDI-Public: 07613336166956
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• 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): 12/29/2025

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 Catalogue Number: 08836981190
• Device Lot Number: 867087
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/02/2025
• Supplement Date Received by Manufacturer: 12/23/2025
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 12/29/2025
• 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