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	07/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event occurred on a cobas 8000 - cobas e 602 module analyzer (serial number: (b)(6).The investigation determined that the elecsys anti-hcv assay performed within its specificity claim.Single false positive results are known to occur and are covered by the assay's performance specifications.The reported anti-hcv results were reactive (44 coi and 46.26 coi) for two samples from the same patient.However, supplemental testing, including enzyme-linked immunosorbent assay (elisa) and hepatitis c virus (hcv) rna testing, yielded non-reactive and negative results, respectively.These findings support the conclusion that the initial results were most likely false positive.The customer was advised to follow the recommendations outlined in the assay's method sheet, which include confirmation testing using supplemental methods.The analyzer remains in operation at the customer site.
Event or Problem Description
The initial reporter alleged a false positive anti-hcv result for one patient sample tested with the anti-hcv g2 elecsys cobas e 100 v2 assay on the cobas 8000 - cobas e 602 module.The initial anti-hcv result was 44 coi (reactive).A new sample from the same patient was tested and yielded a result of 46.26 coi (reactive).Additional testing included enzyme-linked immunosorbent assay (elisa), which was non-reactive, and hepatitis c virus (hcv) rna testing, which was 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: 23070669
• Report Number: 1823260-2025-02972
• Device Sequence Number: 9996617
• Product Code: MZO
• UDI-Device Identifier: 07613336166956
• UDI-Public: 07613336166956
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 09/17/2025

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: 08836981190
• Device Lot Number: 834246
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/16/2025
• 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