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	08/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reports observation of a nonreactive (negative) atellica im hepatitis c (ahcv) result which was discordant relative to patient history and alternate-method testing.A nonreactive (negative) atellica im ahcv result was obtained for a 43-year-old male patient with chronic hcv.The patient, who undergoes regular health checkups and is in stable health with no reported issues, indicated that a previous test at another lab had been reactive (positive).The sample was re-tested, and the initial nonreactive atellica im ahcv result was reproduced, while a roche cobas hcv test produced a strongly reactive (positive) result.Additionally, the same sample was tested the next day using an abbott alinity platform, and a reactive result was obtained.The atellica im ahcv result was identified as a false negative result.There are no allegations of any adverse patient consequences in association with the observed result discordance.
Additional Manufacturer Narrative
A customer from outside the united states reported observation of a nonreactive (negative) atellica im hepatitis c (ahcv) result which was discordant relative to patient history and alternate-method testing.Siemens is investigating.

• 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: barry memishian ; 333 coney st.; east walpole, MA 02032 ; +1(508)298-5306
• MDR Report Key: 50473257
• Report Number: 1219913-2026-00170
• Device Sequence Number: 10395879
• Product Code: MZO
• UDI-Device Identifier: 00630414597867
• UDI-Public: (01)00630414597867(10)79323487(17)270306
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P030056
• 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,Followup
• Report Date (Section B): 09/16/2026

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 Model Number: N/A
• Device Catalogue Number: 10995456
• Device Lot Number: 79323487
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2026
• Supplement Date Received by Manufacturer: 09/15/2026
• Initial Report FDA Received Date: 08/27/2026
• Supplement Report FDA Received Date: 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/06/2026
• 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 Age: 43 YR
• Patient Sex: Male