MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS ANTI-HCV II; ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS

Catalog Number	07026889190
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation about discrepant results for 1 patient sample tested with elecsys anti-hcv ii assay on a cobas e 801 analytical unit.The initial result was 22.3 coi (positive).The patient questioned the initial result.On (b)(6) 2026: the elecsys anti-hcv ii result was 26.0 coi (positive).It is unclear if a new sample was drawn and tested or if the original sample was repeated.A question was asked for clarification, but no answer was provided.Hcv rna (tianlong, gentier 96e) test result: < 50 iu/ml (negative).Abbott ahcv result: 0.07 s/co (tested at another hospital and interpreted as negative).
Additional Manufacturer Narrative
The cobas e 801 analytical unit serial number was (b)(6).The calibration and qc were acceptable.The visual check of the sample showed no visible clots.Per the labeled specificity claim of the assay: single false positive results can occur with the elecsys anti-hcv ii assay.The product labeling states: "reactive: all initially reactive or borderline samples should be retested in duplicate using the elecsys anti-hcv ii assay." the product labeling also states: "repeatedly reactive: 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 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 elecsys ahcv ii assay performs within specifications.The cause of the event could not be determined.

• 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: 24864149
• Report Number: 1823260-2026-01406
• Device Sequence Number: 10476600
• Product Code: MZO
• UDI-Device Identifier: 04015630939947
• UDI-Public: 04015630939947
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P140021
• 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
• Report Date (Section B): 04/13/2026

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: 05/31/2026
• Device Catalogue Number: 07026889190
• Device Lot Number: 86726801
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 04/13/2026
• 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