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 Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter alleged a discrepant negative result for the anti-hcv g2 elecsys e2g 300 assay on the cobas e 801 analytical unit for one patient sample.The negative result was inconsistent with the patient's reported history of a previous hepatitis c virus (hcv) infection.The initial test conducted on (b)(6) 2023 using the anti-hcv g2 elecsys e2g 300 assay yielded a result of 0.0307 coi (non-reactive).A repeat test on (b)(6) 2023 produced a result of 0.0310 coi (non-reactive).Competitor testing of the same sample included abbott, which yielded a result of 6.65 s/co (reactive), and autobio, which yielded a result of 1.935 s/co (reactive).
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 specifications.The sample was subsequently tested using two immunoblot methods: inno-lia fujirebio and recomline mikrogen.The inno-lia result was indeterminate or negative, while the recomline result was clearly negative.Both immunoblots showed only one signal band against the ns3 antigen, which was interpreted as indeterminate or negative according to the respective instructions for use (ifus).The non-reactive result obtained with the elecsys anti-hcv ii assay was considered correct based on confirmatory testing using two immunoblot methods.A review of quality control data indicated that results were within specifications at the time of testing.However, calibration data was not provided for review.The discrepancy between the elecsys anti-hcv ii assay and competitor assays (abbott and autobio) could not be fully clarified without additional follow-up samples or confirmatory analysis of the competitor assay results.The investigation concluded that the elecsys anti-hcv ii assay result was accurate, and no product issue was identified.

• 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: 23075189
• Report Number: 1823260-2025-03018
• Device Sequence Number: 21331392
• Product Code: MZO
• UDI-Device Identifier: 04015630939947
• UDI-Public: 04015630939947
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: 637863
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/15/2023
• 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