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	04/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event occurred on a cobas e 801 analyzer (serial number: (b)(6)).The investigation determined that the elecsys anti-hcv ii assay performed within specifications.A review of calibration and quality control data confirmed that the qc signals were within the specified range, although calibration signals were slightly lower than expected.Patient sample material was requested for further investigation but was not provided.Without the ability to analyze the samples, a definitive root cause for the reported event could not be determined.As stated in the assay method sheet, single false-positive results can occur due to the assay's specificity.The device remains in operation at the customer site.
Event or Problem Description
The initial reporter alleged a possible false positive result for the elecsys anti-hcv ii assay on the cobas e 801 module for one patient sample.The initial sample, drawn on (b)(6) 2020, yielded a reactive result of 14.70 coi.A repeat test on (b)(6) 2020 produced a reactive result of 14.90 coi.A second sample, drawn on (b)(6) 2020, yielded a reactive result of 8.59 coi.A third sample, drawn on (b)(6) 2020, yielded a reactive result of 11.9 coi.Additional testing was conducted using various methods.Hcv viral load testing with the roche cap/ctm method reported the target as not detected.Testing on the abbott i2000 sr system yielded a non-reactive result of 0.21 coi, and testing on the siemens centaur system also yielded a non-reactive result of 0.20 coi.An edta sample drawn on (b)(6) 2020 was tested using the cobas hcv monitoring test on the cobas 6800 system, which also reported the target as not detected.

• 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: 23074841
• Report Number: 1823260-2025-03013
• Device Sequence Number: 4966421
• Product Code: MZO
• UDI-Device Identifier: 04015630939947
• UDI-Public: 04015630939947
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 09/17/2025

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 Expiration Date: 09/30/2020
• Device Catalogue Number: 07026889190
• Device Lot Number: 45913201
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/28/2020
• 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