MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS ANTI-HCV II; HEPATITIS C ANTIBODY ASSAY

Catalog Number	08837058190
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable elecsys anti-hcv ii results for three samples from one patient using the cobas e 801 analytical unit compared to hcv rna (roche) results.The anti-hcv test and the hcv rna test were performed using different collection tubes drawn at the same time.On (b)(6) 2025, the anti-hcv result was 2.52 coi (positive).The hcv rna result was negative.On (b)(6) 2025, the anti-hcv result was 3.67 coi (positive).The hcv rna result was negative.On (b)(6) 2025, the anti-hcv result was 4.22 coi (positive).The hcv rna result was negative.The hospital follows a standard re-testing protocol for hcv in that any sample that initially tests positive is automatically rerun, and in this case, the results showed no discrepancy.No specific repeat results were provided.
Additional Manufacturer Narrative
The cobas e 801 analytical unit serial number was (b)(6).Laboratory quality control results were within the acceptable range during the testing period.The investigation is ongoing.
Additional Manufacturer Narrative
Due to the limited information provided, the investigation was unable to determine a specific root cause.The event was consistent with a sample-specific discrepancy.Per product labeling for the assay, false reactive results may occur as the assay specificity is < 100%.For diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination, and other findings.Based on the provided calibration and qc data, the elecsys anti-hcv ii assay performed within specification.There was no product problem identified.

• Brand Name: ELECSYS ANTI-HCV II
• Common Device Name: HEPATITIS C ANTIBODY ASSAY
• 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: 24280215
• Report Number: 1823260-2026-00430
• Device Sequence Number: 18607278
• Product Code: MZO
• UDI-Device Identifier: 07613336166994
• UDI-Public: 07613336166994
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 03/30/2026

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 Expiration Date: 07/31/2026
• Device Catalogue Number: 08837058190
• Device Lot Number: 867004
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/21/2026
• Supplement Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 02/06/2026
• Supplement Report FDA Received Date: 03/30/2026
• 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