MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA IM HEPATITIS B SURFACE ANTIGEN II (HBSII); TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)

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	11/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This incident occurred outside the united states (ous).The ous customer obtained a non-reactive (negative) result on a plasma sample from a patient with a previous diagnosis of chronic hepatitis b when tested with atellica im hepatitis b surface antigen ii (hbsii) reagent lot 316 on an atellica ci analyzer.The initial atellica ci hbsii negative result was reported and questioned.Retest of the same sample was negative, but positive on an alternate method.The same sample was sent to another lab and tested with 2 other methods (atellica im and a different alternate method) and both results were positive.The customer had a different tube (serum) from the same patient and tested on the atellica ci and resulted positive.A corrected report was issued.There are no reports of altered treatment or adverse health consequences in association with this event.The assay's instructions for use (ifu) states the following, under interpretation of results: "results of this assay should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings." siemens is investigating.
Event or Problem Description
The customer obtained a non-reactive (negative) result on a plasma sample from a patient with a previous diagnosis of chronic hepatitis b when tested with atellica im hepatitis b surface antigen ii (hbsii) reagent lot 316 on an atellica ci analyzer.The initial atellica ci hbsii negative result was reported and questioned.Retest of the same sample was negative, but positive on an alternate method.The same sample was sent to another lab and tested with 2 other methods (atellica im and a different alternate method) and both results were positive.The customer had a different tube (serum) from the same patient and tested on the atellica ci and resulted positive.A corrected report was issued.There are no reports of altered treatment or adverse health consequences in association with this event.
Additional Manufacturer Narrative
Siemens completed the investigation for an outside of the united states (ous) customer complaint of discordant (non-reactive/negative) results on the atellica ci platform using the hepatitis b surface antigen ii (hbsii) assay, lot 316.Patient history indicated chronic hepatitis b virus infection.The same patient sample demonstrated reactive (positive) results on competitor platforms as well as a low-level reactive result on the atellica im platform.A review of reagent performance revealed no anomalies.Quality control data were within acceptable limits, and calibration for the hbsii assay was valid.According to the limitations section of the assay instructions for use: ¿it is recognized that the current methods for the detection of hepatitis b surface antigen may not detect all potentially infected individuals.A nonreactive test result does not exclude the possibility of exposure to or infection with hepatitis b.A nonreactive test result in individuals with prior exposure to hepatitis b may be due to antigen levels below the detection limit of this assay or lack of antigen reactivity to the antibodies in this assay.¿ ¿for diagnostic purposes, the atellica im hbsii test results should always be assessed in conjunction with the patient's medical history, clinical examination, and other findings.¿ the sample was not evaluated for heterophilic antibody interference (hbt or nabt) and insufficient sample volume precluded confirmatory testing.Based on available evidence, the cause of the discordant results cannot be confirmed, but is most likely attributable to sample-specific interference.Possible mechanisms include mutant hepatitis b surface antigen or interference related to chronic infection status.This interpretation is supported by the borderline index value observed on the atellica im platform and reactive results on competitor assays.The customer is operational.A product problem was not identified.Siemens filed initial mdr 1219913-2025-00212 on 21-nov-2025.In section h6 of this report, the investigation finding and conclusion codes were updated based on the investigation results.

• Brand Name: ATELLICA IM HEPATITIS B SURFACE ANTIGEN II (HBSII)
• Common Device Name: TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)
• 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: 23616652
• Report Number: 1219913-2025-00212
• Device Sequence Number: 9997558
• Product Code: LOM
• UDI-Device Identifier: 00630414599274
• UDI-Public: (01)00630414599274(10)38881316(17)260305
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: P110041-S004
• 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): 01/29/2026

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: 03/05/2026
• Device Model Number: N/A
• Device Catalogue Number: 10995604
• Device Lot Number: 38881316
• 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: 11/19/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/05/2025
• 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: Unknown