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

Device Problem False Negative Result (1225)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/12/2023

Event Type  malfunction  

Event 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.

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.

Manufacturer Narrative

Mdr 1219913-2024-00021 was initially filed on (b)(6) 2024.Additional information (07-may-2024): 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.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 hbsll 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 lgg, which it!he 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 cannot 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)
• Type of Device: 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: 18658542
• MDR Text Key: 334744777
• Report Number: 1219913-2024-00021
• Device Sequence Number: 1
• Product Code: LOM
• UDI-Device Identifier: 00630414498096
• UDI-Public: 00630414498096
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/24/2024

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
• Device Operator: 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
• Initial Date Manufacturer Received: 01/12/2024
• Initial Date FDA Received: 02/07/2024
• Supplement Dates Manufacturer Received: 05/07/2024
• Supplement Dates FDA Received: 05/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/20/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Sex: Male