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	12/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event occurred on a cobas e 801 analyzer with serial number (b)(6).The investigation determined that the elecsys anti-hcv ii assay performed within its claimed specificity as outlined in the method sheet.Single false positive results can occur with this assay.The investigation was limited due to the unavailability of sample material, calibration data, and quality control data.A confirmation test by immunoblot, as recommended in the elecsys anti-hcv ii method sheet, was not performed at the customer site.A definitive root cause for the reported event could not be determined based on the available information.E1 initial reporter street line 1: (b)(6).
Event or Problem Description
The initial reporter alleged a false positive result for one patient sample tested with the anti-hcv g2 elecsys e2g 300 assay on the cobas e 801 module.The initial result for the sample was 34.5 coi (reactive).A repeat test on the same system yielded a result of 34.6 coi (reactive).A subsequent test using plasma from the same patient generated a result of 32.7 coi (reactive).Additional testing of the sample included abbott alinity, which yielded a result of 0.14 s/co (negative), and polymerase chain reaction (pcr) for hepatitis c virus (hcv) rna, 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: 23075113
• Report Number: 1823260-2025-03015
• Device Sequence Number: 17304535
• Product Code: MZO
• UDI-Device Identifier: 04015630939947
• UDI-Public: 04015630939947
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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 Catalogue Number: 07026889190
• Device Lot Number: 559196
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/04/2022
• 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