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

Catalog Number	08837031190
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event involved the anti-hcv g2 elecsys cobas e 200 v2 assay on a cobas 6000 e601 module (serial number: (b)(6)).The investigation determined that the anti-hcv g2 elecsys assay performed within specifications based on its specificity claim of 99.85% in blood donors.A review of calibration and quality control data confirmed all results were within expected ranges, and no instrument-related issues were identified.The investigation was limited as no sample material was provided for further analysis.The observed false reactivity is most likely attributable to sample-specific interference.For the eqas sample, potential causes include preservatives or the sample production process.The root cause for the reported false reactivity could not be definitively determined.The device remains in operation at the customer site.
Event or Problem Description
The initial reporter alleged discrepant reactive results with the anti-hcv g2 elecsys cobas e 200 v2 assay on the cobas 6000 e601 module.A patient sample tested reactive for anti-hcv ii with a result of 10.08 coi.This was a follow-up sample collected one year after a previous sample from the same patient, which had been reported as indeterminate in an immunoblot assay.Additionally, a microbiology external quality assessment scheme (eqas) sample tested reactive for anti-hcv ii with a result of 12.61 coi on the cobas 6000 e601 module.The same eqas sample tested non-reactive (0.08 index) on competitor instruments, including abbott and ocd.

• 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: 23095381
• Report Number: 1823260-2025-03170
• Device Sequence Number: 9225315
• Product Code: MZO
• UDI-Device Identifier: 07613336166970
• UDI-Public: 07613336166970
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 09/19/2025

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: 08837031190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/20/2021
• 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