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	05/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens investigated a customer complaint of reactive (positive) atellica im ahbs2 results that were non-reactive (negative) when tested on an alternate test method.Siemens' investigation included an assessment of the following: -reagent issues were ruled out based on review of quality control (qc) data that was provided by the customer which showed recovery within acceptable ranges.-siemens' internal release data was reviewed; reagent lot 175 medical decision pool (mdp) recovery was comparable to the previous lot and following lot of ahbs2.-a review of complaints did not identify a trend for this type of issue for this or any lot numbers for ahbs2 assay.-return of the patient samples was not possible as the sample volume was insufficient to allow for additional analysis, including heterophilic antibody interference testing or repeat testing.Per the atellica im anti-hepatitis b surface antigen 2 (ahbs2) ifu (10995277_en rev.07, 2024-02): "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.Difference in competitor platform results can be attributed to but not limited to antigen/antibody targets, capture and detection antibodies, and signal detection methods, reagent and kit variability, sample handling and matrix effects, biological variability and regulatory and manufacturing standards." "results of this assay should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings." based on the available information, the cause of the discordant result could not be determined, but a product problem was not identified.The customer resumed normal operations after retesting, and the issue has been resolved through routine troubleshooting.
Event or Problem Description
The customer obtained reactive (positive) atellica im ahbs2 results on atellica im analyzer s/n (b)(6).Results were reported to the physician and questioned.When the samples were retested on an alternate method, results were non-reactive (negative).There are no allegations of patient or user intervention or adverse health consequences due to the event.

• 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: 22642240
• Report Number: 1219913-2025-00150
• Device Sequence Number: 12952497
• Product Code: LOM
• UDI-Device Identifier: 00630414597836
• UDI-Public: (01)00630414597836(10)76099175(17)261021
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: P100039
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 07/29/2025

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: 76099175
• 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: 07/15/2025
• Initial Report FDA Received Date: 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/21/2024
• 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