MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA IM HEPATITIS C (AHCV); ASSAY, ENZYME LINKED IMMUNOSORBENT, HEPATITIS C VIRUS

Model Number	N/A
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer complains about discordant non-reactive (negative) atellica im hepatitis c (ahcv) results on one patient compared to positive results with alternate test methods.The patient was first tested at a non-customer site and resulted positive.The sample was sent to the customer site and tested with atellica im hepatitis c (ahcv) for confirmation but resulted negative (non-reactive).The negative result was reported to the physician and questioned.Subsequently, another sample was drawn from the same patient and tested at the initial non-customer site and again resulted positive.The sample was sent to the customer site and tested with atellica im hepatitis c (ahcv) for confirmation but again resulted negative (non-reactive).Another sample was drawn from the patient and sent for hcv pcr testing, which resulted positive.There are no allegations of patient or user intervention or adverse health consequences due to the event.
Additional Manufacturer Narrative
This incident occurred outside the united states (ous).The ous customer complains about discordant non-reactive (negative) atellica im hepatitis c (ahcv) results on one patient compared to positive results with alternate test methods.The patient was first tested at a non-customer site and resulted positive.The sample was sent to the customer site and tested with atellica im hepatitis c (ahcv) for confirmation but resulted negative (non-reactive).The negative result was reported to the physician and questioned.Subsequently, another sample was drawn from the same patient and tested at the initial non-customer site and again resulted positive.The sample was sent to the customer site and tested with atellica im hepatitis c (ahcv) for confirmation but again resulted negative (non-reactive).Another sample was drawn from the patient and sent for hcv pcr testing, which resulted positive.There are no allegations of patient or user intervention or adverse health consequences due to the event.Siemens is investigating.Note: this mdr addresses the discordant result obtained on (b)(6) 2026.A separate mdr is submitted for discordant result obtained on (b)(6) 2026.

• Brand Name: ATELLICA IM HEPATITIS C (AHCV)
• Common Device Name: ASSAY, ENZYME LINKED IMMUNOSORBENT, HEPATITIS C VIRUS
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 333 coney st.; registration # 1219913; east walpole MA 02032
• Manufacturer Contact: stacy loukos ; 333 coney st.; east walpole, MA 02032
• MDR Report Key: 24313265
• Report Number: 1219913-2026-00035
• Device Sequence Number: 4875635
• Product Code: MZO
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P030056
• 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,Followup
• Report Date (Section B): 09/15/2026

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: 04/11/2026
• Device Model Number: N/A
• Device Catalogue Number: 10995456
• Device Lot Number: 36284480
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/11/2026
• Supplement Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/11/2025
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male