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	10/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event occurred on a cobas pure e 402 analytical unit (serial number: (b)(6)).The investigation determined that the elecsys anti-hcv ii assay performed within specifications.The customer did not follow the recommendations outlined in the method sheet for confirmation testing.Specifically, all initially reactive or borderline samples should be retested in duplicate using the elecsys anti-hcv ii assay, and repeatedly reactive samples must be confirmed using supplemental methods such as immunoblot or hcv rna detection.No confirmation testing was performed in this case.Single false positive results are covered by the assay's specificity claim.A definitive root cause for the reported event could not be determined based on the available information.
Event or Problem Description
The initial reporter alleged a false positive result for one patient sample tested with the elecsys anti-hcv ii assay on the cobas pure e 402 analytical unit.The patient sample generated a result of 19.10 cut-off index (coi) with the elecsys anti-hcv ii assay.The same sample was tested with the diasorin method and found to be negative.No immunoblot or polymerase chain reaction (pcr) testing was performed.

• 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: 23099752
• Report Number: 1823260-2025-03262
• Device Sequence Number: 13098220
• Product Code: MZO
• UDI-Device Identifier: 04015630939947
• UDI-Public: 04015630939947
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 09/19/2025

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: 07026889190
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/02/2024
• Initial Report FDA Received Date: 09/19/2025
• 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