MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR ANTI-HEPATITIS B CORE TOTAL (HBCT); 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	10/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A customer from the united states reported observation of a non-reactive hbc total (hbct) result on one patient sample tested with lot 188 on an advia centaur xpt instrument, that was considered discordant relative to a reactive result on a different sample from the same patient using an alternate testing method.The initial advia centaur xpt hbct non-reactive result was reported to the physician(s), who questioned the result.The physician believed the reactive result on the alternate method to be the correct result.Siemens healthcare diagnostics is evaluating.
Event or Problem Description
The customer obtained a non-reactive hbc total (hbct) result on one patient sample tested with lot 188 on an advia centaur xpt instrument, that was considered discordant relative to a reactive result on a different sample from the same patient using an alternate testing method.The initial advia centaur xpt hbct non-reactive result was reported to the physician(s), who questioned the result.The physician believed the reactive result on the alternate method to be the correct result.There are no known reports of patient intervention or adverse health consequences due to this issue.
Additional Manufacturer Narrative
Mdr 1219913-2024-00020 was initially filed on 07-feb-2024.A customer from the united states reported observation of a nonreactive advia centaur hbct result which was discordant relative to alternate-method testing.Siemens has concluded the problem investigation.Instrument performance and reagent issues were ruled out as the hbc total (hbct) results were repeatable across multiple lots and no issues were reported with other patient samples.It is unknown if the patient was vaccinated for hepatitis b virus (hbv).Since the samples are also hbsii nonreactive and anti-hbs reactive, if the patient was not vaccinated it would indicate the patient have recovered from a previous hepatitis b virus (hbv) infection and a reactive anti-hbc result would be expected.The customer did not provide information on whether any of the samples could be tested with the advia centaur hbct2 assay.The architecture of the hbct2 assay has been designed to improve sensitivity to anti-hbc igg, which is the predominant antibody class in patients that have recovered from a previous hbv infection.Based on the available information, the cause of the discordant result and customer status could not be determined, but no product problem was identified.In section h6, the codes for investigation findings, and investigation conclusions were updated.

• Brand Name: ADVIA CENTAUR ANTI-HEPATITIS B CORE TOTAL (HBCT)
• 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 5097
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 333 coney st.; east walpole MA 02032
• Manufacturer Contact: stacy loukos ; 333 coney st.; east walpole, MA 02032 ; 3392064073
• MDR Report Key: 18658532
• Report Number: 1219913-2024-00020
• Device Sequence Number: 8241094
• Product Code: LOM
• UDI-Device Identifier: 00630414498096
• UDI-Public: 00630414498096
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P040004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2024

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: 02/20/2024
• Device Model Number: N/A
• Device Catalogue Number: 10309508
• Device Lot Number: 188
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/12/2024
• Supplement Date Received by Manufacturer: 05/13/2024
• Initial Report FDA Received Date: 02/07/2024
• Supplement Report FDA Received Date: 05/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/20/2023
• 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: 71 YR
• Patient Sex: Male