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

Catalog Number	08837058190
Medical Device Problem Codes	False Positive Result (1227); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The e402 analyzer serial number was (b)(6).
Event or Problem Description
The initial reporter questioned positive results for 1 patient sample tested for elecsys anti-hcv ii (anti-hcv ii) on a cobas e 402 analytical unit.Note: the unit of measure was not provided.The initial result from the e402 analyzer was 92.40 (positive).The repeat result was 92.90 (positive).The sample was repeated at a reference laboratory, where the result from the abbott method was "negative." the specific result was not provided.
Additional Manufacturer Narrative
Medwatch fields updated: - a2 date of birth.- a3a sex.- b6 relevant tests/laboratory data,inclu.- b7 other relevant history.- d4 lot no.- d4 expiration date.The customer stated that the result was unconfirmed by the hcv antibody and antigen results from the referral laboratory that uses an abbott architect.The investigation reviewed the data set provided by the customer: the calibration results were within the specified ranges.The qc results were within the specified ranges, but the qc level 2 results were fluctuating.The alarm trace had a "reagent below" warning.Elecsys anti-hcv ii (anti-hcv ii) product labeling states: "coi - 0.90, = coi, < 1.00.Result - border.Interpretation of results - borderline zone (undetermined).Interpretation/further steps - retest in duplicate with the elecsys anti-hcv ii assay.Coi - = 1.00.Result - reactive.Interpretation of results - antibodies to hcv detected.Interpretation/further steps - presumptive hcv infection, 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." a general reagent issue was excluded.The investigation determined that the assay is performing according to 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: 23842561
• Report Number: 1823260-2025-05227
• Device Sequence Number: 9835799
• Product Code: MZO
• UDI-Device Identifier: 07613336166994
• UDI-Public: 07613336166994
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• 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): 01/15/2026

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: 09/30/2026
• Device Catalogue Number: 08837058190
• Device Lot Number: 875907
• 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: 12/03/2025
• Supplement Date Received by Manufacturer: 12/19/2025
• Initial Report FDA Received Date: 12/18/2025
• Supplement Report FDA Received Date: 01/15/2026
• 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 Age: 83 YR
• Patient Sex: Female