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

Catalog Number	08836981190
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event occurred on a cobas e 601 analyzer (serial number: (b)(6).The investigation determined that the elecsys anti-hcv ii assay performed within specifications.Calibration and quality control data were reviewed and found to be within the specified ranges.No instrument alarms were reported, and no pre-analytical issues were identified.The investigation was limited as the patient sample material was not available for further analysis.False positive results can occur with the elecsys anti-hcv ii assay due to its specificity of 99.85%, as stated in the method sheet.A definitive cause for the reported event could not be determined.The customer was advised to follow the method sheet recommendations, including retesting reactive samples in duplicate and confirming results using supplemental methods such as immunoblot or hcv rna detection.
Event or Problem Description
The initial reporter alleged a discrepant positive result for the elecsys anti-hcv ii assay on the cobas 6000 e601 module when compared to a negative result obtained using an abbott assay.The elecsys anti-hcv ii assay generated a positive result, while the abbott assay generated a negative result.

• 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: 23089120
• Report Number: 1823260-2025-03154
• Device Sequence Number: 18603896
• Product Code: MZO
• UDI-Device Identifier: 07613336166956
• UDI-Public: 07613336166956
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• 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
• Report Date (Section B): 09/18/2025

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 Expiration Date: 06/30/2023
• Device Catalogue Number: 08836981190
• Device Lot Number: 65293001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/18/2023
• Initial Report FDA Received Date: 09/18/2025
• 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