MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA IM ANTI-HEPATITIS B SURFACE ANTIGEN 2 (AHBS2); HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)

Model Number	N/A
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A customer obtained a discordant reactive (positive) result with atellica im anti-hepatitis b surface antigen 2 (ahbs2) that was non-reactive (negative) when the same sample was tested on an alternate method.The initial reactive result was reported and questioned by the physician.A corrected report was issued.There are no allegations of patient or user intervention or adverse health consequences due to the discordant reactive ahbs2 result.
Additional Manufacturer Narrative
A customer obtained a discordant reactive (positive) result with atellica im anti-hepatitis b surface antigen 2 (ahbs2) that was non-reactive (negative) when the same sample was tested on an alternate method.The customer indicated that the physician had initially expected the hepatitis b antibody to be not detected because the patient had a strong reactive result for hepatitis b antigen (result was not provided).The limitations section of the assay instructions for use (ifu) states: "assay performance characteristics have not been established for the atellica im ahbs2 assay used in conjunction with other manufacturers' assays for specific hbv serological markers." the interpretation of results section of the ifu states: "results of this assay should always be interpreted in conjunction with the patient¿s medical history, clinical presentation, and other findings." siemens is investigating this event.
Additional Manufacturer Narrative
Siemens investigated an outside of the united states (ous) customer observation of a discordant reactive (positive) result with atellica im anti-hepatitis b surface antigen 2 (ahbs2) lot 163 that was non-reactive (negative) when the same sample was tested on an alternate method.Quality control (qc) was within acceptable ranges and no issues were reported with other patient samples.The customer treated the patient sample with heterophilic blocking tube (hbt) and results were lower as expected.Based on the available information, the cause of the discordant result is a sample specific interference.The customer is operational, and the reported issue is resolved by routine troubleshooting.In section h6 of this report, the investigation finding and conclusion codes were updated based on the investigation results.

• Brand Name: ATELLICA IM ANTI-HEPATITIS B SURFACE ANTIGEN 2 (AHBS2)
• Common Device Name: 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 ; 3392064073
• MDR Report Key: 18753966
• Report Number: 1219913-2024-00036
• Device Sequence Number: 3703236
• Product Code: LOM
• UDI-Device Identifier: 00630414597836
• UDI-Public: 00630414597836
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: P100039-S005
• 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): 02/11/2025

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: 10995453
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/27/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/21/2024
• Supplement Report FDA Received Date: 02/11/2025
• 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: Unknown