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

Catalog Number	08836981190
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter alleged discrepant elecsys hbsag ii and elecsys anti-hcv ii assay results for three patient samples tested on the cobas e 411 analyzer (rack system).This medwatch is for the elecsys anti-hcv ii assay.Please refer to the medwatch with a1.Patient identifier (b)(6) for the elecsys hbsag ii assay.Patient sample 1: the initial result from the analyzer was 33.89 coi (reactive).The first repeat result from a mini vidas system was 0.06*.The unit of measurement and/or interpretation was not provided.
Additional Manufacturer Narrative
The cobas e 411 analyzer (rack system) serial number is (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
The customer stated that the reported patient sample was low in volume and had foam.The customer did not run level 1 qc on the date of the event.Good laboratory practice precludes running and/or reporting patient results when qc has failed or not been performed.The investigation determined the event was consistent with a preanalytic issue at the customer's site (sample quality).Preanalytics are within the customer's responsibility.There was no indication of a device malfunction.

• 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: 25002385
• Report Number: 1823260-2026-01650
• Device Sequence Number: 9813434
• Product Code: MZO
• UDI-Device Identifier: 07613336166956
• UDI-Public: 07613336166956
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• PMA/510(K) Number: K221693
• 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,Followup
• Report Date (Section B): 06/03/2026

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 Expiration Date: 05/31/2026
• Device Catalogue Number: 08836981190
• Device Lot Number: 887765
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/04/2026
• Supplement Date Received by Manufacturer: 05/12/2026
• Initial Report FDA Received Date: 04/27/2026
• Supplement Report FDA Received Date: 06/03/2026
• 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