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

Catalog Number	08836981190
Medical Device Problem Codes	False Positive Result (1227); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of a questionable elecsys anti-hcv ii result from the cobas 6000 e601 module for one patient.The initial result was 2.16 coi (reactive), accompanied by an alarm that the reagent was expired.The repeat result with a new reagent cassette was 2.34 coi (reactive).A new sample was collected and sent to an external laboratory using an architect analyzer, with a result of 0.09 coi (negative).The polymerase chain reaction (pcr) result was negative, <15.The unit of measurement was requested but not provided at this time.
Additional Manufacturer Narrative
The cobas 6000 e601 module serial number is (b)(6).The customer reported that control level 2 was out of range for the old cassette, but no data was provided.The new cassette qc was okay, but low.The customer swapped the reagent to a different module to rule out a reagent vs.Instrument issue: no errors were observed in the calibration or qc data.Per product labeling, "all initially reactive or borderline samples should be retested in duplicate using the elecsys anti-hcv ii assay.For repeatedly reactive samples, confirmation via supplemental methods (e.G.Immunoblot or detection of hcv rna).If one or both measurements remain borderline the analysis of a follow-up sample is recommended." a general reagent issue can be excluded, as the reagent performed according to specification.The investigation is ongoing.
Additional Manufacturer Narrative
The unit of measurement for the polymerase chain reaction (pcr) result was provided as iu/ml.The investigation did not identify a product problem.

• 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: 24376917
• Report Number: 1823260-2026-00562
• Device Sequence Number: 14871913
• Product Code: MZO
• UDI-Device Identifier: 07613336166956
• UDI-Public: 07613336166956
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 03/13/2026

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: 07/31/2026
• Device Catalogue Number: 08836981190
• Device Lot Number: 906685
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/27/2026
• Supplement Date Received by Manufacturer: 02/19/2026
• Initial Report FDA Received Date: 02/18/2026
• Supplement Report FDA Received Date: 03/13/2026
• 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