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 Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas e 411 analyzer (rack system) serial number is (b)(6).The field service engineer inspected the analyzer and performed internal checks.He also cleaned the analyzer, retested the patient samples, and verified that it is performing according to specifications.The investigation reviewed the data set provided by the customer: the calibration results were within the specified ranges.The qc results were within the specified ranges.Product labeling states: "interpretation of the results - all initially reactive or borderline samples should be retested in duplicate using the elecsys anti-hcv ii assay." "retest result - one or both of the duplicate retests have a coi = 0.9.Final result/interpretation - repeatedly reactive further steps - confirmation via supplemental methods (e.G.Immunoblot or detection of hcv rna).If one or both measurements remain borderline the analysis of a follow-up sample is recommended." the investigation determined that single false positive results can occur and are covered by the assay's specificity claim.The elecsys anti-hcv ii is performing according to specifications.The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable elecsys anti-hcv ii results for 2 patient samples tested on the cobas e 411 analyzer (rack system).Patient samples 1 and 2's historical anti-hcv results were "negative".The elecsys anti-hcv ii results were "positive".The confirmatory results from a service laboratory were "positive." the questionable results were not reported outside the laboratory.

• 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: 24799466
• Report Number: 1823260-2026-01321
• Device Sequence Number: 16122744
• 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,Followup
• Report Date (Section B): 06/05/2026

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: 906685
• 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: 03/11/2026
• Supplement Date Received by Manufacturer: 05/13/2026
• Initial Report FDA Received Date: 04/07/2026
• Supplement Report FDA Received Date: 06/05/2026
• 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