MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS ANTI-HCV II; HEPATITIS C ANTIBODY ASSAY

Catalog Number	08837058190
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable elecsys anti-hcv ii results from the cobas e 402 analytical unit and a cobas e 801 analyzer for one patient.On (b)(6) 2026: the initial result was 31.3 coi (reactive).The repeat result was 31.4 coi (reactive).On (b)(6) 2026: the repeat result from the fujirebio hcv score, which uses the line immunoassay (lia) laboratory method, was negative.On (b)(6) 2026: the patient sample was sent to the investigation laboratory.The repeat result on an e801 analyzer was 32.6 coi (reactive).The repeat result was 32.9 coi (reactive).The repeat result from an analyzer that uses the chemiluminescence immunoassay (clia) laboratory method was 0.19 (negative).
Additional Manufacturer Narrative
The cobas e 402 analytical unit serial number is (b)(6).The cobas e 801 analyzer serial number is (b)(6).The investigation laboratory's elecsys anti-hcv ii reagent lot number was not provided.Per product labeling: "result >/= to 1.00 coi - reactive presumptive hcv infection, follow cdc recommendations for supplemental testing." "result after retest (coi) - if 2 of the 3 results have a coi = 1.00 presumptive evidence of antibodies to hcv.Follow cdc recommendations for supplemental testing." "false positive results due to non-specific reactivity cannot be ruled out with the elecsys anti-hcv ii assay." "in rare cases, interference due to extremely high titers of antibodies to streptavidin or ruthenium can occur.These effects are minimized by suitable test design." "for diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings." the investigation determined that the elecsys anti-hcv ii assay is performing within specifications.

• Brand Name: ELECSYS ANTI-HCV II
• Common Device Name: HEPATITIS C ANTIBODY ASSAY
• 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: 25068412
• Report Number: 1823260-2026-01723
• Device Sequence Number: 10357612
• Product Code: MZO
• UDI-Device Identifier: 07613336166994
• UDI-Public: 07613336166994
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K221693
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• 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): 05/04/2026

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: 08837058190
• Device Lot Number: 90665201, 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: 04/13/2026
• Initial Report FDA Received Date: 05/04/2026
• 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