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	10/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event occurred on a cobas e 801 analytical unit with serial number (b)(6).The investigation determined that the anti-hcv g2 elecsys e2g 300 assay performed within specifications.A review of calibration and quality control data confirmed that all results were within expected ranges.The reagent was confirmed to be functioning as intended at the customer site.Immunoblot testing conducted locally confirmed the results to be false positive.The specificity of the assay, as stated in the instructions for use, accounts for the occurrence of single false positive results.
Event or Problem Description
The initial reporter alleged a discrepant positive result for the anti-hcv g2 elecsys e2g 300 assay on the cobas e 801 analytical unit.On (b)(6) 2022, a patient sample tested positive with a result of 16 coi, which was repeated and confirmed.On (b)(6) 2022, a new blood sample was drawn, and the result was 12.1 coi.Subsequent testing at other laboratories using an immunological test, likely on an abbott system, yielded negative results.Immunoblot testing for both samples also produced clear negative results.The patient did not receive treatment for hepatitis c virus (hcv) based on the positive results, as clarified by the attending doctors.The results were ultimately confirmed to be false positive.

• 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: 23088914
• Report Number: 1823260-2025-03141
• Device Sequence Number: 18590925
• Product Code: MZO
• UDI-Device Identifier: 04015630939947
• UDI-Public: 04015630939947
• Combination Product (Y/N): N
• Initial Reporter Country: LH
• 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): 09/18/2025

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: 04/30/2023
• Device Catalogue Number: 07026889190
• Device Lot Number: 61720702
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/14/2022
• 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 Age: 31 YR
• Patient Sex: Male