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	02/10/2023
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.The estimated specificity at the customer site, based on the reported results, was calculated to be 99.84%, which is consistent with the claimed specificity of the assay.The investigation was limited by the unavailability of confirmation testing using an independent immunoblot analysis.Additionally, sample quality issues, such as hemolysis, could not be excluded as contributing factors.Drifting quality control results over time suggested potential issues related to reagent and/or process control handling, storage, or instrument maintenance.The root cause of the reported event could not be definitively determined based on the available information.
Event or Problem Description
The initial reporter alleged that false positive results were generated with the anti-hcv g2 elecsys e2g 300 assay on the cobas e 801 analytical unit throughout the year 2023.The customer reported 10 samples from 10 different patients that were repeatedly reactive with the anti-hcv g2 elecsys e2g 300 assay but were non-reactive when tested on the abbott architect system.The customer considers these results as false positives based on the comparison to abbott architect results.No confirmation of the reactive results with an independent immunoblot analysis was available.The samples in question were from non-healthy patients, all of whom were on medications.The customer indicated the use of gel separation tubes (3.5 and 4 ml) for sample collection but could not confirm whether the samples were lipemic, hemolysate, or icteric.Some samples were noted to show hemolysis.Four of the 10 samples were available for further investigation, but two of these did not meet sample quality specifications due to hemolysis.

• 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: 23100526
• Report Number: 1823260-2025-03302
• Device Sequence Number: 8685368
• Product Code: MZO
• UDI-Device Identifier: 04015630939947
• UDI-Public: 04015630939947
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: 04/30/2023
• Device Catalogue Number: 07026889190
• Device Lot Number: 617207
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/24/2023
• 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