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	03/05/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
The customer reports observation of a reactive atellica im anti-hepatitis b surface antigen 2 (ahbs2) result which was discordant relative to clinical indications and alternate-method testing.Ahbs2 kit lot 164 was in use at the time.The affected patient was initially tested for ahbs2 and hepatitis b surface antigen; reactive results were obtained for both tests (which is clinically unexpected).The next day, an alternate-method result for hbsag was positive.When the sample was sent out for alternate-method anti-hbs testing, a negative result was obtained.The negative ahbs result was accepted as correct, as simultaneous reactive results for both hbs and anti-hbs is considered clinically inconsistent.There are no allegations of patient harm or other adverse consequences in association with the observed discordance.
Additional Manufacturer Narrative
Mdr 1219913-2024-00256 was initially submitted on 28-mar-24.Update, april 2024: siemens has concluded the investigation.A customer from outside the united states reported observation of a reactive atellica im anti-hepatitis b surface antigen 2 (ahbs2) result which was discordant relative to clinical indications and alternate-method testing.Quality control (qc) results were within acceptable ranges, and no issues were observed with any other samples.Assay calibration data did not indicate any issues.On the basis of this information, general reagent issues were ruled out as a likely cause.Service was dispatched to review instrument performance and perform comprehensive instrument maintenance.There were no instrument observations to explain the identified result discordance.Sample material was not made available to permit additional testing.Although a specific cause was not identified, based on the available information, the discordant result may be attributable to a sample-specific interferent.It is noted that other hepatitis assays also produced reactive results which were inconsistent with the patient¿s clinical presentation.The assay¿s instructions for use (ifu) advises 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.¿ no product problem was identified.The customer is operational, and no further action is required.Note: in section h6, 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
• Manufacturer Contact: barry memishian ; 333 coney st.; east walpole, MA 10591 ; 5082985306
• MDR Report Key: 19000062
• Report Number: 1219913-2024-00256
• Device Sequence Number: 14161315
• Product Code: LOM
• UDI-Device Identifier: 00630414597836
• UDI-Public: 00630414597836
• Combination Product (Y/N): N
• 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): 04/24/2024

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): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 04/24/2024
• Initial Report FDA Received Date: 03/28/2024
• Supplement Report FDA Received Date: 04/24/2024
• 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 Sex: Unknown