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 06/15/2023

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 185 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 11-year-old male patient was tested for pre-therapeutic assessment before jak inhibitor treatment (rheumatoid arthritis).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

The initial mdr 1219913-2023-00243 was filed on 28-sep-2023.Additional information received on 03-oct-2023: a customer from outside the united states reported observation of a patient sample that was nonreactive (0.39 index vs a cutoff of 0.50 index) with atellica im anti-hbc total antibody (hbct) kit lot 185 but reactive with the atellica im hbct2 and liaison hbct assays.The sample was also hbsag nonreactive, anti-hbs nonreactive, anti-hbe nonreactive, and hcv nonreactive.Siemens has evaluated the information provided by the customer and the instrument data.Reagent issues were ruled out based on review of qc which showed recovery within acceptable ranges and no issues were reported with other patient samples.It is rare for a sample to be anti-hbc positive when all other tests are negative.However, it may indicate immunity where ahbs levels have become undetectable or it can also indicate chronic replicative infection where the hbsag levels are undetectable and serum dna levels may be low.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 with this one sample is consistent with expected assay performance.The customer is operational.In section h6, investigation findings and investigation conclusions codes are updated.

• 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 MA 02032
• Manufacturer Contact: louise mclaughlin ; 333 coney st.; east walpole, MA 02032 ; 7818564812
• MDR Report Key: 17832220
• MDR Text Key: 324447325
• Report Number: 1219913-2023-00243
• Device Sequence Number: 1
• Product Code: LOM
• UDI-Device Identifier: 00630414599205
• UDI-Public: 00630414599205
• 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: 10/27/2023

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: 12/18/2023
• Device Model Number: N/A
• Device Catalogue Number: 10995597
• Device Lot Number: 185
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/18/2023
• Initial Date FDA Received: 09/28/2023
• Supplement Dates Manufacturer Received: 10/03/2023
• Supplement Dates FDA Received: 10/27/2023
• 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: 11 YR
• Patient Sex: Male