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	09/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This incident occurred outside the united states (ous).Siemens concluded the investigation of an ous customer observation a reactive (positive) atellica im anti-hepatitis b surface antigen 2 (ahbs2) result that was non-reactive (negative) when the sample was tested on an alternate test method.The negative retest was believed to be correct.The assay's instructions for use (ifu) states the following, under interpretation of results: "results of this assay should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings." siemens's investigation included an assessment of the following: reagent issues were ruled out based on review of quality control (qc), which showed recovery within acceptable ranges and no issues were reported with other patient samples.Calibration data showed valid calibration for the ahbs2 assay.Additional infectious disease assays were also reactive on this patient sample.The customer was unable to perform additional testing such as non-specific antibody tube (nabt) and heterophilic block tubes (hbt) for ahbs2 due to insufficient volume of patient sample.Return of the patient sample for further investigation is not possible as sample volume is insufficient.Based on the available information, the cause of the discordant result is consistent with a sample specific interferent.The customer is operational, and the reported issue is resolved by routine troubleshooting.
Event or Problem Description
The customer obtained a reactive (positive) atellica im anti-hepatitis b surface antigen 2 (ahbs2) result that was non-reactive (negative) when the sample was tested on an alternate test method.The negative retest was believed to be correct.The initial reactive result was not reported.There is no allegation 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: 20514329
• Report Number: 1219913-2024-00445
• Device Sequence Number: 15231435
• Product Code: LOM
• UDI-Device Identifier: 00630414597836
• UDI-Public: (01)00630414597836(10)49066168(17)260108
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 10/23/2024

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: 01/08/2026
• Device Model Number: N/A
• Device Catalogue Number: 10995453
• Device Lot Number: 49066168
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/09/2024
• Initial Report FDA Received Date: 10/23/2024
• Date Device Manufactured: 01/08/2024
• 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: 67 YR
• Patient Sex: Male