MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA IM ANTI-HEPATITIS B SURFACE ANTIGEN 2 (AHBS2); TEST, 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	02/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This incident occurred outside the united states (ous).The ous customer reported an observation of repeat reactive atellica im anti-hepatitis b surface antigen 2 (ahbs2), lot: 174 patient sample results which were not in accordance with the patient history and alternate method testing.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.Note: this mdr addresses the discordant results for sample id: (b)(6) (test date: on (b)(6) 2025).The discordant result for sample id: (b)(6) (test date: on (b)(6) 2025) is being reported in separate mdr.
Event or Problem Description
The customer obtained a repeat reactive atellica im anti-hepatitis b surface antigen 2 (ahbs2), lot: 174 result on a patient sample (id: (b)(6) which was not in accordance with the patient history and alternate method testing.The discordant atellica im ahbs2 reactive results were not reported to the physician(s).There are no allegations of patient harm, changes in treatment, or delays of diagnosis in association with this event.
Additional Manufacturer Narrative
Siemens filed initial mdr 1219913-2025-00053 on 15-mar-2025.Siemens investigated an outside of the united states customer report of repeat reactive atellica im anti-hepatitis b surface antigen 2 (ahbs2), lot 174 results on a patient which was not in accordance with the patient history and alternate method testing.The investigation included an assessment of the following which ruled out product issues: a review of the quality control (qc) that was provided by the customer.It showed recovery within acceptable ranges.No issues were reported with other patient samples.Calibration data was reviewed and was found to be valid and acceptable.Per the atellica im anti-hepatitis b surface antigen 2 (ahbs2) instructions for use (ifu 10995278_en rev.07_us and ifu 10995277_en rev.07_ous): "results of this assay should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings." "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.Laboratories are responsible for establishing their own performance characteristics." additionally, ifu 10995277_en rev.07_ous lists the 95% confidence interval (ci) for resolved relative specificity as 98.34% - 99.88% so a certain number of false positive results can be expected for this assay.Discordant results may occur when comparing platforms based on the specific assay design.These differences include sensitivity and the ability to detect both wild-type and mutant hbv strains.Other issues to consider are the patient history of vaccination, clinical diagnosis and inherent patient sample interferences.Based on the available information, the cause of the discordant result cannot be determined, but appears to be a patient/sample specific interferant.The customer is operational, and the reported issue is resolved by routine troubleshooting.Mdr 1219913-2025-00053 supplemental 1 is for the discordant result for sample id (b)(6) (test date 2025-02-14).Mdr 1219913-2025-00054 supplemental 1 is for discordant result for sample id (b)(6) (test date 2025-02-10).

• Brand Name: ATELLICA IM ANTI-HEPATITIS B SURFACE ANTIGEN 2 (AHBS2)
• 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: 21612963
• Report Number: 1219913-2025-00053
• Device Sequence Number: 7624981
• Product Code: LOM
• UDI-Device Identifier: 00630414597836
• UDI-Public: (01)00630414597836(10)50062174(17)260903
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 05/06/2025

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: 09/03/2026
• Device Model Number: N/A
• Device Catalogue Number: 10995453
• Device Lot Number: 50062174
• 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: 03/05/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/14/2025
• Supplement Report FDA Received Date: 05/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/03/2024
• 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 Age: 66 YR
• Patient Sex: Male