MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA IM 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 06/08/2023

Event Type  malfunction  

Event Description

The customer reports observation of a nonreactive atellica im anti-hepatitis b core total (hbct) result which was discordant relative to alternate-method testing.Hbct kit lot 182 was in use at the time of the discordant observation.The customer is performing a comparison study wherein previously-tested patient samples are re-tested for correlation against a new method.During this comparison study, a sample was identified for which the initial hbct measurement was nonreactive (negative), but testing using atellica im hbct2 (new method) as well as an additional alternate method produced reactive (positive) results.The initial nonreactive hbct result was retrospectively identified as discordant and potentially falsely negative by comparison with the new test results.This 63-year-old male patient was undergoing hbv screening at the time due to increased levels of liver transaminases.There are no allegations of patient harm, changes in treatment, or delays of diagnosis in association with the observed discordance.

Manufacturer Narrative

A customer from outside the united states reported observation of a nonreactive atellica im anti-hepatitis b core total (hbct) result which was discordant relative to alternate-method testing.The assay's instructions for use (ifu) states the following, under limitations: "the performance of the assay has not been established for populations of immunocompromised or immunosuppressed patients." siemens is investigating.

Manufacturer Narrative

Mdr 1219913-2023-00202 was initially submitted on 2023-09-20.A customer from outside the united states reported observation of a nonreactive atellica im anti-hepatitis b core total (hbct) result which was discordant relative to alternate-method testing.Additional information, 2023-09-29: siemens has concluded the investigation.The hbct result was nonreactive (0.41 index, vs.Cutoff of 0.50 index).Atellica im hbct2 and an alternate-method hbct assay produced reactive (positive) results.The sample was also hbsag nonreactive and anti-hbs reactive indicating this patient has recovered from an earlier hepatitis b virus (hbv) infection.Reagent issues were ruled out, as quality control (qc) results were within appropriate ranges and no issues were identified for any other patient samples.As the sample was initially tested in (b)(6) 2023, instrument data are no longer available to permit evaluation of whether an instrument issue may have contributed to the event.It is noted that the architecture of the (alternate) 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 for this sample cannot be determined, but siemens cannot rule out an analyzer issue or an isolated anomalous result within normal assay performance.The customer is operational, and no product problem was identified.

• Brand Name: ATELLICA IM 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
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 333 coney st.; east walpole 02032
• Manufacturer Contact: barry memishian ; 333 coney st.; east walpole, MA 02032 ; 5082985306
• MDR Report Key: 17785755
• MDR Text Key: 323903871
• Report Number: 1219913-2023-00202
• Device Sequence Number: 1
• Product Code: LOM
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P040004-S013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/12/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 11/09/2023
• Device Model Number: N/A
• Device Catalogue Number: 10995597
• Device Lot Number: 182
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/15/2023
• Initial Date FDA Received: 09/20/2023
• Supplement Dates Manufacturer Received: 09/29/2023
• Supplement Dates FDA Received: 10/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2022
• 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: 63 YR
• Patient Sex: Male