MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA IM HEPATITIS B SURFACE ANTIGEN II (HBSII)

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	06/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An initial mdr 1219913-2025-00141 was filed on 11-jul-2025.Corrected data (19-aug-2025): in the initial report, the following statement was mentioned: based on the available information, the cause of the discordant result was unable to be determined due to improper storage of patient samples prior to confirmatory testing.However, it should have been as follows: based on the available information, the cause of the discordant result was potentially due to improper storage of patient samples prior to confirmatory testing.The investigation conclusion code in section h6 has been updated to reflect the change.
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted the siemens remote services center (rsc) and reported observation of a nonreactive (negative) hepatitis b surface antigen (hbsag), confirmatory (hbsii conf) result which was discordant relative to clinical expectation and repeat testing.Siemens reviewed the instrument data and the information provided by the customer.Reagent and instrument issues were ruled out based on quality control (qc) recovery within acceptable ranges, valid calibration and no issues were reported with other patient samples.Siemens identified that the patient sample was stored incorrectly at room temperature for greater than 8 hours prior to hbsii confirmatory testing.However, per the assay's instructions for use (ifu), "primary tube samples are stable for up to 8 hours at room temperature or onboard the system".The samples must be stored at 2-8 degrees celsius if the sample has to be stored greater than 8 hours.Return of the patient sample for further investigation was not warranted, as the customer performed appropriate repeat testing per the assay's ifu.Based on the available information, the cause of the discordant result was unable to be determined due to improper storage of patient samples prior to confirmatory testing.The issue was resolved by routine troubleshooting; a product problem was not identified.The customer is operational, and no further actions are required.
Event or Problem Description
The customer reported observation of a nonreactive (negative) atellica im hepatitis b surface antigen (hbsag), confirmatory (hbsii conf) result which was discordant relative to clinical expectation repeat testing when using lot# 314.An initial reactive (positive) result was obtained for the patient in question.Per the assay¿s instructions for use (ifu), the initial reactive patient samples should be repeated in duplicate, the best 2 of 3 should be considered the patients¿ initial result and to be confirmed with the atellica im hbsag confirmatory assay, additional hbv marker assays, or another approved confirmatory method if warranted or necessary.The customer followed the assay instructions for use (ifu) and repeated the sample.The results were repeatedly reactive.The reactive result was not reported to the physician(s).A confirmatory testing was performed which produced an initial reactive (positive) result.Per the assay's instructions for use (ifu), "samples which are neutralized <50% but whose relative light units (rlus) value are above the hbsii conf cutoff, get diluted 1/50".The instrument auto repeated the sample with dilution (x50) that resulted in a 'not confirmed' (negative) result.This result was considered discordant as the customer was expecting a reactive (positive) result for the affected patient.The same sample was retested and obtained a 'confirmed' (positive) result, which was considered correct and reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to this event.

• Brand Name: ATELLICA IM HEPATITIS B SURFACE ANTIGEN II (HBSII)
• Common Device Name: ATELLICA IM HEPATITIS B SURFACE ANTIGEN II (HBSII)
• 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: varsha joshi ; pritech park sez, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; 870577433
• MDR Report Key: 22479420
• Report Number: 1219913-2025-00141
• Device Sequence Number: 20818956
• Product Code: LOM
• UDI-Device Identifier: 00630414599274
• UDI-Public: (01)00630414599274(10)60755314(17)250917
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: P110041-S004
• 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): 08/25/2025

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: 09/17/2025
• Device Model Number: N/A
• Device Catalogue Number: 10995604
• Device Lot Number: 60755314
• 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: 06/16/2025
• Supplement Date Received by Manufacturer: 08/19/2025
• Initial Report FDA Received Date: 07/11/2025
• Supplement Report FDA Received Date: 08/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/17/2024
• 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: 77 YR
• Patient Sex: Male