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

Catalog Number	08837031190
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event occurred on a cobas e 602 analyzer with serial number: (b)(6).The investigation determined that the elecsys anti-hcv ii assay performed within specifications.The patient sample was tested during the investigation, and the elecsys anti-hcv ii assay result was confirmed as reactive.An additional 2 different blots testing produced indeterminate results during the investigation.The root cause was attributed to a sample-specific discrepancy, likely due to the detection of residual antibodies to hcv in an individual who had cleared the virus.
Event or Problem Description
The initial reporter alleged discrepant reactive results for one patient sample tested with the elecsys anti-hcv ii assay on the cobas e 602 module.On (b)(6) 2024, the elecsys anti-hcv ii assay generated a reactive result of 119.5 coi for the patient sample.No flags or alarms were reported, and the sample was not diluted.Subsequent genomic testing produced an indeterminate result with an ns3 band.Testing with the abbott anti-hcv assay on the architect i 1000sr at two different hospitals yielded negative results.Rna testing for hcv using the cobas e 5800 system also produced a negative result.The patient was identified as a dialysis patient with no clinical evidence or history of a hepatitis c infection.

• 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: 23070580
• Report Number: 1823260-2025-02959
• Device Sequence Number: 14693941
• Product Code: MZO
• UDI-Device Identifier: 07613336166970
• UDI-Public: 07613336166970
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K221693
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• 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): 09/17/2025

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: 08837031190
• Device Lot Number: 748184
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/06/2024
• Initial Report FDA Received Date: 09/17/2025
• 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