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	12/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reports observation of nonreactive (negative) atellica im hepatitis b surface antigen ii (hbsii) results which were discordant relative to clinical expectation and alternate-method testing when using hbsii lot 312.The customer indicates that a particular patient has produced negative (nonreactive) hbsii results on several occasions (details not provided), and that later testing showed this patient to be hepatitis b positive.There are no allegations of patient harm, changes in treatment, or delays of diagnosis in association with the observed discordance.
Additional Manufacturer Narrative
A united states customer reported observation of nonreactive (negative) atellica im hepatitis b surface antigen ii (hbsii) results which were discordant relative to clinical expectation and alternate-method testing the hbsii assay's instructions for use (ifu) states the following, under interpretation of results: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings." siemens is evaluating.
Additional Manufacturer Narrative
A customer from outside the united states reported observation of nonreactive (negative) atellica im hepatitis b surface antigen ii (hbsii) results which were discordant relative to clinical expectation and alternate-method testing.Mdr 1219913-2025-00025 was initially submitted on 18-jan-2025.Update, 13-mar-2025: siemens has concluded the investigation.Reagent issues were essentially ruled out, as quality control (qc) results were within expected ranges, and no issues were observed for any other samples.Calibration data showed valid calibration for the hbsii assay.A sample was provided to siemens for investigational testing.In triplicate testing, this sample produced reproducibly nonreactive results.Additionally, the sample was tested following pre-treatment with a heterophilic blocking tube (hbt); these results were also nonreactive.The customer¿s observations were reproduced in the testing at siemens.The following is noted in the atellica im hbsii instructions for use (ifu), under limitations: ¿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.Patients taking biotin supplements may have false negative results with this assay.Patient samples containing biotin of greater than 75 ng/ml may produce false negative results.¿ based on the available information, the observed discordance is consistent with a sample-specific interferent such as a mutant antigen, nondetectable antigen levels or an interference associated with a supplement or prescribed medication.The customer is operational, and the reported issue was resolved by routine troubleshooting.No systemic product issue was identified.Note: in section h6, the codes for investigation findings, and investigation conclusions have been updated.

• 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 no. 1219913; east walpole MA 02032
• Manufacturer Contact: barry memishian ; 333 coney st.; east walpole, MA 02032 ; 5082985306
• MDR Report Key: 21185738
• Report Number: 1219913-2025-00025
• Device Sequence Number: 15587861
• Product Code: LOM
• UDI-Device Identifier: 00630414599274
• UDI-Public: (01)00630414599274(17)14944312(17)250604
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2025

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 Expiration Date: 06/04/2025
• Device Model Number: N/A
• Device Catalogue Number: 10995604
• Device Lot Number: 14944312
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/14/2025
• Supplement Date Received by Manufacturer: 03/13/2025
• Initial Report FDA Received Date: 01/17/2025
• Supplement Report FDA Received Date: 03/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/04/2024
• 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