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	12/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The e801 analyzer serial number was (b)(6).
Event or Problem Description
The initial reporter questioned positive results for 1 patient sample tested for elecsys anti-hcv ii (anti-hcv ii) on a cobas e 801 analytical unit.The initial result was 10.1 coi (positive).The repeat result was 9.92 coi (positive).The repeat result from an unspecified competitor method was 0.35 c/co (negative).
Additional Manufacturer Narrative
The field service engineer (fse) decontaminated the instrument.The customer has had no further issues.Calibration and qc were acceptable.A sample aspiration error was observed on the alarm trace data.Product labeling states: "reactive in the elecsys anti-hcv ii assay.All initially reactive samples should be retested in duplicate with the elecsys anti-hcv ii assay.Redetermination of samples with an initial coi = 1.00 can be performed automatically.Repeatedly reactive samples must be confirmed according to supplementary algorithms.A cobas e flow is a procedure programmed into the system to enable a fully automated sequence of measurements and the calculation of assay combinations to perform decision algorithms." single false positive results can occur and are covered by the specificity claim.A general reagent issue can be excluded.The reagent performed within specification.

• 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: 23850950
• Report Number: 1823260-2025-05248
• Device Sequence Number: 9527451
• Product Code: MZO
• UDI-Device Identifier: 07613336166994
• UDI-Public: 07613336166994
• Combination Product (Y/N): N
• Initial Reporter Country: PE
• 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): 02/04/2026

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: 01/31/2026
• Device Catalogue Number: 08837058190
• Device Lot Number: 823050
• 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: 12/04/2025
• Supplement Date Received by Manufacturer: 01/16/2026
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 02/04/2026
• 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 Age: 49 YR
• Patient Sex: Male
• Patient Ethnicity: Hispanic