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	07/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer serial number was not provided.The investigation determined that the anti-hcv g2 elecsys e2g 300 assay performed within specifications.Further testing of the sample was conducted with the anti-hcv ii assay on a cobas e 601 analyzer, generating a result of 10.74 coi (reactive).The sample was also tested with the fujirebio inno-lia hcv score, which was negative.A review of the available data indicated that the reported false positive result was most likely sample-related.Additional testing, including the fujirebio inno-lia hcv score and other confirmatory methods, yielded negative results, supporting the conclusion of a false positive.Calibration and quality control data were not provided, which limited the investigation.The reagent was confirmed to be performing as expected, and no product issue was identified.
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 (b)(6) 2021, the patient sample was tested with the anti-hcv g2 elecsys e2g 300 assay and generated a result of 13.4 coi (reactive).A new blood sample from the same patient was tested on (b)(6) 2021, generating a result of 10.8 coi (reactive).Additional testing of the sample from (b)(6) 2021 included abbott architect, which was negative; an antibody test (monolisa biorad elisa), which was negative; and an immunoblot (fujirebio inno-lia), which was negative.Polymerase chain reaction (pcr) testing was also negative.

• 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: 23098317
• Report Number: 1823260-2025-03238
• Device Sequence Number: 18478439
• Product Code: MZO
• UDI-Device Identifier: 04015630939947
• UDI-Public: 04015630939947
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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 Expiration Date: 11/30/2021
• Device Catalogue Number: 07026889190
• Device Lot Number: 53025201
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/27/2021
• 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