MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD. ATELLICA IM HBC TOTAL 2 (HBCT2); QUALITATIVE AND QUANTITATIVE HEPATITIS B VIRUS ANTIBODY ASSAYS

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	03/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer obtained of a non-reactive (negative) patient result using atellica im hbc total 2 (hbct2) lot 017.The result was not reported as the patient was known to have hepatitis b.The sample was retested using an alternate method and the result was reactive (positive) as expected.There are no allegations of patient or user intervention or adverse health consequences due to the event.The limitations section of the instructions for use (ifu) states, the following: "results of this assay should always be interpreted in conjunction with the patient¿s medical history, clinical presentation, and other findings." findings." "patient samples may contain heterophilic antibodies that could react in immunoassays to give falsely elevated or depressed results.This assay is designed to minimize interference from heterophilic antibodies.Additional information may be required for diagnosis." siemens is investigating.
Event or Problem Description
The customer obtained of a non-reactive (negative) patient result using atellica im hbc total 2 (hbct2) lot 017.The result was not reported as the patient was known to have hepatitis b.The sample was retested using an alternate method and the result was reactive (positive) as expected.There are no allegations of patient or user intervention or adverse health consequences due to the event.

• Brand Name: ATELLICA IM HBC TOTAL 2 (HBCT2)
• Common Device Name: QUALITATIVE AND QUANTITATIVE HEPATITIS B VIRUS ANTIBODY ASSAYS
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD.; glyn rhonwy, llanberis; gwynedd LL55 4EL; UK LL55 4EL
• 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: 24670095
• Report Number: 1219913-2026-00060
• Device Sequence Number: 5042802
• Product Code: SEI
• UDI-Device Identifier: 00630414604138
• UDI-Public: (01)00630414604138(10)06403017(17)270911
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P210019
• 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): 05/20/2026

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: 11200739
• Device Lot Number: 06403017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2026
• Supplement Date Received by Manufacturer: 04/06/2026
• Initial Report FDA Received Date: 03/23/2026
• Supplement Report FDA Received Date: 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/11/2025
• 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 Age: 78 YR
• Patient Sex: Male