MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA IM HEPATITIS B SURFACE ANTIGEN II (HBSII); TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)

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	03/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A customer from outside the united states reported observation of nonreactive (negative) atellica im hepatitis b surface antigen ii (hbsii) results for one patient which were discordant relative to patient medical history and alternate-method testing.When the patient's sample was re-tested using an alternate method at an alternate site, a positive result was obtained which was considered consistent with the patient¿s medical history.No issues were noted with assay quality control (qc).There are no allegations of patient harm, changes in treatment, or delays of diagnosis in association with the observed result discordance.Siemens is investigating.
Event or Problem Description
The customer reports observation of nonreactive atellica im hepatitis b surface antigen ii (hbsii) results for one patient which were discordant relative to patient medical history and alternate-method testing.A nonreactive hbsii result was obtained for an 85-year-old male patient.This result was reported to the physician and questioned.The same sample was tested using an alternate method at an external lab, and a positive result was returned, which was considered consistent with the patient¿s medical history.The customer states that re-testing of the sample following dilution (2-fold and 4-fold) also produced nonreactive hbsii results.There are no reports that treatment was altered or prescribed or of adverse health consequences due to the discordant nonreactive atellica im hbsagii results.
Additional Manufacturer Narrative
Mdr 2432235-2023-00183 was initially reported on 2023-06-23.A customer from outside the united states reported observation of nonreactive atellica im hepatitis b surface antigen ii (hbsii) results for one patient which were discordant relative to patient medical history and alternate-method testing.Siemens reviewed the available information and data, including customer quality control (qc) results, which were within assigned ranges.No similar complaints were identified in a search of the complaint database.Additional information has been requested from the customer on multiple occasions, but none has been provided.Further evaluation is not possible without additional information.On the basis of the available information, no product problem was identified.The customer is operational.Note: in section h6, the codes for investigation findings and investigation conclusion have been updated.

• Brand Name: ATELLICA IM HEPATITIS B SURFACE ANTIGEN II (HBSII)
• Common Device Name: TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS; 333 coney st.; east walpole MA 02032
• Manufacturer Contact: barry memishian ; 511 benedict ave.; tarrytown, NY 10591 ; 5082985306
• MDR Report Key: 17190483
• Report Number: 2432235-2023-00183
• Device Sequence Number: 5806612
• Product Code: LOM
• UDI-Device Identifier: 00630414599274
• UDI-Public: 00630414599274
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P110041-S004
• 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): 09/15/2023

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: 08/11/2023
• Device Model Number: N/A
• Device Catalogue Number: 10995604
• Device Lot Number: 281
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/24/2023
• Supplement Date Received by Manufacturer: 08/31/2023
• Initial Report FDA Received Date: 06/23/2023
• Supplement Report FDA Received Date: 09/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2022
• 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: 85 YR
• Patient Sex: Male