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	02/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reports observation of reactive atellica im anti-hepatitis b surface antigen 2 (ahbs2) results which were discordant relative to alternate-method testing.Ahbs2 kit lot 164 was in use at the time.The customer obtained reproducible reactive ahbs2 results on three test dates for a 30-year-old male patient.Repeat testing using two alternate methods produced negative results which conflicted with the earlier reactive results.The customer is uncertain which results to consider correct.Due to the conflicting indications, the reactive atellica im ahbs2 results are considered potential false positive observations.There are no allegations of any adverse patient consequences in association with the observed discordance.Quality control (qc) results were within expected ranges when these ahbs2 tests were run.
Additional Manufacturer Narrative
A customer from outside the united sates reported observation of a reactive (positive) atellica im anti-hepatitis b surface antigen 2 (ahbs2) result which was discordant relative to alternate-method testing.The atellica im ahbs2 instructions for use (ifu) states the following, under interpretation of results: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings." siemens is investigating.
Additional Manufacturer Narrative
Mdr 1219913-2024-00280 was initially submitted on 03-apr-2024.Siemens has concluded the investigation.A customer from outside the united sates reported observation of a reactive (positive) atellica im anti-hepatitis b surface antigen 2 (ahbs2) result which was discordant relative to alternate-method testing.Initial testing of this patient using ahbs2 in (b)(6) was reproducibly reactive, across three samples and two atellica im instruments.Siemens investigation included review of customer assay and instrument data.Reagent issues were ruled out, as quality control (qc) results were within acceptable ranges and no issues were reported for other patient samples.No issues were identified with assay calibration.In (b)(6) , the customer performed follow-up testing, treating one of the discordant samples using a non-specific antibody blocking tube (nabt) and a heterophilic block tube (hbt).Both pre-treated samples produced much lower (nonreactive) ahbs2 results: initial (discordant) result: 105 iu/l (reactive, = 12.0 miu/ml).With nabt tube: 3.10 iu/l (nonreactive, < 8.0 miu/ml).With hbt tube: 4.82 iu/l (nonreactive, < 8.0 miu/ml).Follow-up testing indicates that the probable cause for the discordant result is a sample-specific interferent.Return of the patient sample for further internal investigation by siemens is not warranted because the customer has conducted appropriate testing.No product problem was identified.The customer is operational, and the reported issue was resolved by routine troubleshooting.Note: in section h6, the codes for investigation findings and investigation conclusions have been updated.

• 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.; east walpole MA 02032 ; AG 02032
• Manufacturer Contact: barry memishian ; 333 coney st.; east walpole, MA 02032 ; 5082985306
• MDR Report Key: 19033544
• Report Number: 1219913-2024-00280
• Device Sequence Number: 8120695
• Product Code: LOM
• UDI-Device Identifier: 00630414597836
• UDI-Public: 00630414597836
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K192790
• 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): 06/11/2024

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: 06/06/2025
• Device Model Number: N/A
• Device Catalogue Number: 10995453
• Device Lot Number: 164
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/02/2024
• Supplement Date Received by Manufacturer: 06/07/2024
• Initial Report FDA Received Date: 04/03/2024
• Supplement Report FDA Received Date: 06/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2023
• 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: 30 YR
• Patient Sex: Male