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	05/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The anti-hcv g2 reagent expiration date was not provided.The reported event occurred on a cobas e411 analyzer (serial number: (b)(6).The investigation was limited due to the unavailability of sample material, instrument data, and additional testing details.A definitive root cause for the reported event could not be determined.However, single false reactive results can occur and are covered by the assay's specificity claim.The customer was advised to follow the instructions for use, which recommend duplicate retesting of initially reactive samples and confirmatory testing for repeatedly reactive results.
Event or Problem Description
The initial reporter alleged a discrepant positive result with the anti-hcv g2 elecsys cobas e 100 v2 assay on the cobas e411 rack instrument.The sample in question tested positive with the elecsys anti-hcv ii assay.Additional testing included abbott anti-hcv (ahcv) and polymerase chain reaction (pcr), both of which were 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: 23081530
• Report Number: 1823260-2025-03073
• Device Sequence Number: 9997001
• Product Code: MZO
• UDI-Device Identifier: 07613336166956
• UDI-Public: 07613336166956
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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): 09/18/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 08836981190
• 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: 05/22/2025
• 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 Sex: Unknown