MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR ANTI-HBS2 (AHBS2) ASSAY; TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)

Model Number	N/A
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reports observation of a reactive (positive) advia centaur anti-hbs2 (ahbs2) result for one patient sample when using lot 165 which was discordant relative to repeat testing using another reagent lot.An initial strongly reactive result was obtained for the patient in question using ahbs2 lot 165; this result was not reported to the physician.The sample was repeated twice using reagent lot 160, producing consistent nonreactive (negative) results.The nonreactive results were considered correct, as they were in agreement with the clinical picture for this patient.There are no known reports of patient intervention or adverse health consequences due to the observed result discordance.
Additional Manufacturer Narrative
A customer from outside the united sates reported observation of a reactive (positive) advia centaur xp anti-hepatitis b surface antigen 2 (ahbs2) result which was discordant relative to repeat testing using another reagent lot.The same sample was additionally tested for troubleshooting/investigation purposes using atellica im 1600 ahbs2 reagent lot 166, and much higher (reactive) results were observed.The elevated result was reproduced in testing of a 10-fold diluted sample.Quality control (qc) results for ahbs2 were within expected ranges, and no instrument errors were found with the system during these events.Siemens is investigating.
Additional Manufacturer Narrative
Mdr 1219913-2024-00308 was initially filed on 16-may-2024.Additional information 28-may-2024: siemens has concluded the investigation.A customer from outside the united states reported observation of a reactive (positive) advia centaur xp anti-hepatitis b surface antigen 2 (ahbs2) result which was discordant relative to repeat testing using another reagent lot.The same sample was additionally tested for troubleshooting/investigation purposes using atellica im 1600 ahbs2 reagent lot 166, and much higher (reactive) results were observed.The elevated result was reproduced in testing of a 10-fold diluted sample.Quality control (qc) results for ahbs2 were within expected ranges.Reagent performance issues were essentially ruled out, as qc results were within range, and no problems were reported for any other patients.It is not known why the customer repeated ahbs2 testing on an alternate lot of ahbs2 reagent.Although a specific cause could not be identified, the observation is consistent with preanalytical (sample quality) issues.The customer was unable to verify whether the sample used to produce the discordant results was compromised, as no additional testing was performed.Return of the sample and any additional investigation are not possible due to depletion of the affected sample.No product problem was idenfitied; the customer is operational, and no further action is required.Note: in section h6, the codes for investigation findings and investigation conclusions have been updated.

• Brand Name: ADVIA CENTAUR ANTI-HBS2 (AHBS2) ASSAY
• 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: barry memishian ; 333 coney st.; registration #1219913; east walpole, MA 02032 ; 5082985306
• MDR Report Key: 19332234
• Report Number: 1219913-2024-00308
• Device Sequence Number: 7003672
• Product Code: LOM
• UDI-Device Identifier: 00630414591407
• UDI-Public: 00630414591407
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P100039
• 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,Followup
• Report Date (Section B): 06/05/2024

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: 06/07/2025
• Device Model Number: N/A
• Device Catalogue Number: 10286268
• Device Lot Number: 165
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/08/2024
• Supplement Date Received by Manufacturer: 05/28/2024
• Initial Report FDA Received Date: 05/16/2024
• Supplement Report FDA Received Date: 06/05/2024
• 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: 45 YR
• Patient Sex: Female