MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LTD. ATELLICA IM HBC TOTAL 2 (HBCT2); TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)

Model Number	N/A
Medical Device Problem Codes	False Negative Result (1225); False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer notified siemens of a non-reactive (negative) atellica im anti-hepatitis b core total2 (hbct2) lot 016 result that was later found to be discordant relative to the retesting of the patient on a different date with atellica im and an alternate method.The patient was being routinely tested for hepatitis b since 2022 as well as other infectious diseases.The patient resulted as negative in (b)(6) 2025 with atellica im hbct2.The patient returned in (b)(6) 2025 and was tested again and the atellica im hbct2 result was positive.Because of the discrepancy in results, both the (b)(6) samples were retested with an alternate method, and results were positive and believed to be correct.There are no allegations of patient harm, changes in treatment, or delays of diagnosis in association with this event.Quality control (qc) and calibrations were within acceptance criteria at the time of testing.Siemens is investigating.
Event or Problem Description
The customer notified siemens of a non-reactive (negative) atellica im anti-hepatitis b core total2 (hbct2) lot 016 result that was later found to be discordant relative to the retesting of the patient on a different date with atellica im and an alternate method.The patient was being routinely tested for hepatitis b since 2022 as well as other infectious diseases.The patient resulted as negative in (b)(6) 2025 with atellica im hbct2.The patient returned in (b)(6) 2025 and was tested again and the atellica im hbct2 result was positive.Because of the discrepancy in results, both the (b)(6) samples were retested with an alternate method, and results were positive and believed to be correct.There are no allegations of patient harm, changes in treatment, or delays of diagnosis in association with this event.
Additional Manufacturer Narrative
Siemens filed mdr 1219913-2025-00167 initial report on 15-sep-2025.Correction: section d3 of mdr 1219913-2025-00167 initial report that was filed on 15-sep-2025 lists the incorrect legal manufacturer information.Section d3 of this supplemental report contains the correct legal manufacturer information.Additional information: siemens completed the investigation for this event.The initial complaint involved an alleged false negative result for atellica im anti-hepatitis b core total 2 (hbct2) lot: 016 on (sample id: (b)(6), tested on (b)(6) 2025) compared to an alternate method.During the collaborative investigation by siemens and the customer, it was clarified that the negative result was correct and consistent with the patient¿s medical history.The actual concern was identified with sample id: (b)(6) from the same patient, which produced a positive result using atellica im hbct2 lot: 016 on (b)(6) 2025; this positive result was considered erroneous.No impact to patient diagnosis or treatment was reported.Sections 1.2b (date of incident) and 3.2a (medical device problem code) have been updated accordingly.Results data obtained during the investigation for the patient in question are as follows: sample id: (b)(6): on (b)(6) 2025 - atellica im (s/n: (b)(6) result: non-reactive 0.42 index ¿ considered correct.Additional results obtained during customer troubleshooting/investigation: on (b)(6) 2025 - alternate test method 1 result: reactive 0.781 index- considered false positive.On (b)(6) 2025 ¿ atellica im (s/n: (b)(6) result: 0.44 index (non-reactive) ¿ considered correct.Sample id: (b)(6): on (b)(6) 2025: atellica im (s/n: (b)(6) result: 5.65 index (reactive) ¿ discordant, false positive.Additional results obtained during customer troubleshooting/investigation: on (b)(6) 2025: alternate atellica im (s/n: (b)(6) result: 6.34 index (reactive) - discordant, false positive.On (b)(6) 2025: alternate test method 1 result: 0.625 index (reactive) - considered false positive.Alternate test method 2 result: non-reactive (value/date not provided) ¿ considered correct.Quality control (qc) remained within range throughout customer testing.Reagent issues were ruled out based on review of qc which showed recovery within acceptable ranges and no issues were reported with other patient samples.After investigation, the atellica im hbct2 lot: 016 non-reactive result was confirmed to be the correct result.Siemens concluded that the patient (a 43-year-old female vaccinated for hepatitis b) had a clinical history of being non-reactive for hbct2, but index values increased over time leading to false positive results with sample: (b)(6).While the exact cause of the discordant results on this sample from on (b)(6) 2025, cannot be confirmed, the issue appears to be specific to the patient and/or the sample.History of hbct2 testing for this patient: <0.07 (on (b)(6) 2022, on (b)(6) 2023 0.25 (on (b)(6) 2024 0.42 (on (b)(6) 2025 5.65/6.34 positive (on (b)(6) 2025.The patient has a documented history of being negative for hepatitis b and continues to test negative on the second alternate test method and is consistently positive for anti-hbs antibodies (including results from march and august), which indicates immunity to the hepatitis b virus, confirmed by the customer that the patient was previously vaccinated.Heterophilic blocking tubes (hbt) and non-specific binding tubes (nabt) were sent to the customer to check for potential interferents; no results were reported back.Siemens followed up, but the customer declined to respond.Return of the patient sample in question (b)(6) for further investigation is not warranted because the customer has conducted appropriate testing and has declined to provide further information.Based on the investigation, the cause of the discordant result cannot be confirmed, but appears to be isolated to a single patient sample.The customer is operational, and the issue has been resolved by routine troubleshooting.In section h6 of this report, the medical device problem code, investigation finding and conclusion codes have been updated based on the investigation results.

• Brand Name: ATELLICA IM HBC TOTAL 2 (HBCT2)
• Common Device Name: TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LTD.; glyn rhonwy, llanberis; caernarfon, gwynedd NY LL55 4EL; UK LL55 4EL
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 333 coney st.; east walpole MA 02032
• Manufacturer Contact: stacy loukos ; 333 coney st.; east walpole, MA 02032
• MDR Report Key: 23048179
• Report Number: 1219913-2025-00167
• Device Sequence Number: 9741841
• Product Code: LOM
• UDI-Device Identifier: 00630414604138
• UDI-Public: (01)00630414604138(10)09486016(17)270128
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P210019
• 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): 12/05/2025

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: 11200739
• Device Lot Number: 09486016
• 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: 09/03/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/14/2025
• Supplement Report FDA Received Date: 12/05/2025
• Date Device Manufactured: 01/28/2025
• 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: 43 YR
• Patient Sex: Female