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 10/06/2023

Event Type  malfunction  

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 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.

• 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: 18658532
• MDR Text Key: 334784988
• Report Number: 1219913-2024-00020
• Device Sequence Number: 1
• Product Code: LOM
• 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
• Report Date: 02/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2024
• 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
• Date Manufacturer Received: 01/12/2024
• 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: 71 YR
• Patient Sex: Male