MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA IM ANTI-HEPATITIS B CORE TOTAL (HBCT)

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	04/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reports an observation of false negative (non-reactive) atellica im anti-hepatitis b core total (hbct) results which were considered discordant relative to repeat testing on alternate methods.The atellica im hbct instructions for use (ifu) states the cutoff for the assay is 0.50 index.However the customer set the reference range of 0-1 index for non-reactive results.An initial negative (non-reactive) hbct result was obtained for a patient sample.The negative result obtained was reported to the physician(s), who questioned the result.The sample was retested on the original atellica im analyzer and obtained a similar negative (non-reactive) result.The same sample was retested on alternate test methods and obtained positive (reactive) results.These repeat results were considered correct since they matched the clinical diagnosis of the patient, and the alternate test method 1 result was reported as correct result to the physician(s).A corrected report was issued based on the repeat testing.There are no known reports of delay, patient intervention, or adverse health consequences due to this event.
Additional Manufacturer Narrative
A customer from outside the united states (ous) reported an observation of false negative (non-reactive) atellica im anti-hepatitis b core total (hbct) results which were considered discordant relative to repeat testing on alternate methods.The assay's instructions for use (ifu) states the following, under interpretation of results: the cutoff for the assay is 0.50 index so the results of 0.75 index and 0.58 index are both reactive.Siemens informed the customer that samples with two or more out of three results showing an index value of = 0.50 should be considered reactive for anti-hbc total.Additionally, siemens provided training on result interpretation based on the guidelines outlined in the atellica im hbct instructions for use (ifu).Return of the patient sample for further investigation is not warranted because the sample is not discordant.A product problem has not been identified.The customer is operational.

• Brand Name: ATELLICA IM ANTI-HEPATITIS B CORE TOTAL (HBCT)
• Common Device Name: ATELLICA IM ANTI-HEPATITIS B CORE TOTAL (HBCT)
• 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: 21948785
• Report Number: 1219913-2025-00092
• Device Sequence Number: 9056606
• Product Code: LOM
• UDI-Device Identifier: 00630414599205
• UDI-Public: (01)00630414599205(10)50846203(17)251008
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P040004-S013
• 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
• Report Date (Section B): 05/02/2025

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: 10/08/2025
• Device Model Number: N/A
• Device Catalogue Number: 10995597
• Device Lot Number: 50846203
• 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: 04/23/2025
• Initial Report FDA Received Date: 05/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/08/2024
• 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: 62 YR
• Patient Sex: Female