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	01/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This incident occurred outside the united states (ous).The ous customer notified siemens of a discordance between atellica im anti-hepatitis b surface antigen 2 (ahbs2) lot: 174 patient result relative to a retest result with a different lot.There are no allegations of patient or user intervention or adverse health consequences due to the event.Per the interpretation of results section of the assay instructions for use (ifu): "nonreactive: samples with an initial value < 8.0 miu/ml are considered nonreactive (negative) for antibodies to hepatitis b surface antigen.Reactive: samples with an initial value = 12.0 miu/ml are considered reactive (positive) for antibodies to hepatitis b surface antigen.Retest zone: samples with an initial value = 8.0 miu/ml and < 12.0 miu/ml will be flagged for retest.These samples should be retested in duplicate.After retesting, if at least 2 results are < 10.0 miu/ml, then the sample is considered to be nonreactive.If at least 2 results are = 10.0 miu/ml, then the sample is considered to be reactive." "results of this assay should always be interpreted in conjunction with the patient¿s medical history, clinical presentation, and other findings." the customer does not perform retesting for samples resulting = 8.0 miu/ml and < 12.0 miu/ml, therefore, this report is conservatively.Siemens is investigating.
Event or Problem Description
The customer notified siemens of a discordance between atellica im anti-hepatitis b surface antigen 2 (ahbs2) lot: 174 patient result relative to a retest result with a different lot.The patient was initially tested with atellica im ahbs2 lot: 174 and resulted in the reactive range (>12 miu/ml).This result was reported to the physician and not questioned.The customer performed a retest of the same sample on the same analyzer, on a different day, with a different reagent lot (lot: 175) as part of a look back activity.The retest result was lower than the initial result.It is unknown whether a corrected report was issued to the physician.There are no allegations of patient or user intervention or adverse health consequences due to the event.
Additional Manufacturer Narrative
Siemens completed investigation for an outside the united states (ous) customer report of a reactive atellica im anti-hepatitis b surface antigen 2 (ahbs2) lot 174 patient result relative to a non-reactive retest result obtained with a different reagent lot on a different day.Siemens reviewed the positive and negative quality control (qc) for bias and control means.All data provided by the customer was within acceptable levels of package insert qc ranges.Calibration data showed valid calibration for the assay.Initial result was reported to physician and not questioned.Additional information received from the customer indicated that patient sample was stored incorrectly at 5-8 degrees celsius for greater than 7 days prior to retesting.Per the assay instructions for use (ifu), store samples capped at all times at 2¿8°c for up to 7 days.Freeze samples, devoid of red blood cells, at = -20°c for longer storage.Do not store in a frost-free freezer.The customer declined to provide any additional information about this issue; therefore, siemens was unable to further investigate this issue.Based on the available information, the cause of the discordance is inconclusive, but may be a result of improper storage of patient samples prior to retest.The customer is operational, and the reported issue is resolved by routine troubleshooting.Siemens filed initial mdr on 01-apr-2025.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: 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: 21750843
• Report Number: 1219913-2025-00063
• Device Sequence Number: 12817218
• Product Code: LOM
• UDI-Device Identifier: 00630414597836
• UDI-Public: (01)00630414597836(10)50062174(17)260903
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 06/12/2025

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/02/2025
• Supplement Report FDA Received Date: 06/11/2025
• 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: 45 YR
• Patient Sex: Female