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

Catalog Number	08837058190
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas e 801 analytical unit serial number was (b)(6).The calibration and qc were acceptable.The investigation is ongoing.
Event or Problem Description
We received an allegation about discrepant negative results for 3 patients' samples tested with elecsys anti-hcv ii assay on a cobas e 801 analytical unit.Patient 1: initial result: 0.0501 col (interpreted as negative).1st repeat result: 3.24 col (tested on alinity and interpreted as positive).2nd repeat result: 1.02 col (tested on atellica and interpreted as positive).Riba blot (recombinant immunoblot assay) test result was indeterminate.Patient 2: initial result: 0.0456 col (interpreted as negative).1st repeat result: 4.65 col (tested on alinity and interpreted as positive).2nd repeat result: 0.63 col (tested on atellica and interpreted as negative).Riba blot (recombinant immunoblot assay) test result was negative.Patient 3: initial result: 0.0643 col (interpreted as negative).1st repeat result: 3.85 col (tested on alinity and interpreted as positive).2nd repeat result: 0.92 col (tested on atellica and interpreted as equivocal).Riba blot (recombinant immunoblot assay) test result was indeterminate.No questionable results were reported to the patients.The 1st repeat results were considered to be correct.
Additional Manufacturer Narrative
No alarm trace from 03-dec-2025 provided.The samples for patient 1 and patient 3: a single false negative elecsys result might occur.Based on the indeterminate immunoblot results, neither the negative elecsys result nor the positive alinity result was confirmed to be true or false.A final assessment was not possible.The sample for patient 2: the negative immunoblot result clearly confirmed the elecsys result and the false positive alinity result.A follow-up sample was highly recommended.The product labeling states: "for diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings." the investigation did not identify a product problem.The reagent performs within specifications.The cause of the event could not be determined.

• 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: 23850488
• Report Number: 1823260-2025-05239
• Device Sequence Number: 9527395
• Product Code: MZO
• UDI-Device Identifier: 07613336166994
• UDI-Public: 07613336166994
• 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): 01/30/2026

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: 86700401
• 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: 12/03/2025
• Supplement Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 01/30/2026
• 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: Male