MAUDE Adverse Event Report: Roche Diagnostics Elecsys Anti-HCV II; Hepatitis C Antibody Assay

Catalog Number	08837058190
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	08/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation about discrepant results for 2 patients' samples tested with elecsys anti-hcv ii assay on a cobas e 801 analytical unit.Patient 1: initial result: 1.62 coi (reactive).1st repeat result: 1.65 coi (reactive).2nd repeat result: 1.65 coi (reactive).On (b)(6)2026, the sample was repeated at a different customer's branch: 3rd repeat result: non-reactive (tested using the electrochemiluminescence immunoassay (eclia) method).The result was confirmed by an enzyme-linked fluorescent assay (elfa) method.Patient 2 was tested on (b)(6)2026: initial result: 2.75 coi (reactive).1st repeat result: 2.80 coi (reactive).2nd repeat result: 2.78 coi (reactive).On (b)(6)2026: the result from another laboratory, which uses the chemiluminescence immunoassay (clia) method, was 0.11 s/co (negative).
Additional Manufacturer Narrative
The cobas e 801 analytical unit serial number was (b)(6).The investigation is ongoing.

• Brand Name: Elecsys Anti-HCV II
• Common Device Name: Hepatitis C Antibody Assay
• Manufacturer (Section D): Roche Diagnostics; 9115 hague road; indianapolis IN 46250 -045
• 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: 50898152
• Report Number: 1823260-2026-03952
• Device Sequence Number: 10706207
• Product Code: MZO
• UDI-Device Identifier: 07613336166994
• UDI-Public: 07613336166994
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• PMA/510(K) Number: K221693
• Number of Events Summarized: 1
• Summary Report (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): 09/25/2026

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: 931391
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 09/25/2026
• 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