MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS ANTI-HCV II; ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS

Catalog Number	07026889190
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter alleged discrepant positive anti-hcv g2 elecsys e2g 300 results for two patient samples tested on a cobas e 801 analytical unit.For sample 1, the anti-hcv results were 13.6 (daughter tube) and 12.4 (mother tube) at uch, and 14.3 on the cobas e 801.For sample 2, the anti-hcv results were 8.77 (daughter tube) and 8.69 (mother tube) at uch, and 8.58 on the cobas e 801.Testing of the same samples at the local government reference laboratory (phlc) using competitor methods, including merux, ortho-blot, and vidas (biomerieux), yielded negative anti-hcv results.Polymerase chain reaction (pcr) testing at the same reference laboratory also did not detect hcv rna.
Additional Manufacturer Narrative
The reported event involved a cobas e 801 analytical unit (serial number: (b)(6).The investigation determined that the elecsys anti-hcv assay performed within its specificity claim.Single false positive results are known to occur and are covered by the assay's performance characteristics.The investigation was limited as original data and patient history were not available.Testing at the local government reference laboratory (phlc) using competitor methods, including merux, ortho-blot, and vidas (biomerieux), yielded negative anti-hcv results, and pcr testing did not detect hcv rna.These findings suggest the samples were likely false positive for the elecsys anti-hcv assay.The device remains in operation at the customer site.Supplemental testing, as outlined in the assay method sheet, is recommended for repeatedly reactive samples to confirm results.

• 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: 23075313
• Report Number: 1823260-2025-03021
• Device Sequence Number: 4965973
• Product Code: MZO
• UDI-Device Identifier: 04015630939947
• UDI-Public: 04015630939947
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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: 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: 05/27/2024
• 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