MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD. ATELLICA IM HBC TOTAL 2 (HBCT2); 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 10/29/2023

Event Type  malfunction  

Event Description

The customer reports observation of nonreactive (negative) atellica im hbc total 2 (hbct2) results which were discordant relative to alternate-method testing.Hbct2 lot 008 was in use at the time.A nonreactive (negative) hbct2 result was obtained for a 28-year-old male patient with a history of a positive ahbct result 6 months earlier.This negative result was not reported to the physician.Re-testing of the same sample using the atellica im anti-hepatitis b core total (hbct) test produced a reactive (positive) result.The customer sent this patient¿s sample to another laboratory for confirmation.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 (negative) atellica im hbc total 2 (hbct2) results which were discordant relative to patient history and alternate-method testing.Testing was repeated for investigation purposes.Both methods (hbct2 and hbct) reproduced the initial observations: negative by hbct2, positive by hbct.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." "patient samples may contain heterophilic antibodies that could react in immunoassays to give falsely elevated or depressed results.This assay is designed to minimize interference from heterophilic antibodies.Additional information may be required for diagnosis." siemens is investigating.

Manufacturer Narrative

Mdr 1219913-2023-00283 was initially submitted on 2023-11-07.A customer from outside the united states reported observation of nonreactive (negative) atellica im hbc total 2 (hbct2) results which were discordant relative to alternate-method testing.Atellica im hbct2 results for this patient were reproducibly negative, while hbct results were reactive (positive).The patient's sample was tested at an external lab using a third method, and a negative result was returned.Based on the available information, the probable cause for the discordant results is a sample-specific assay interferent.The customer is operational, and no product problem was identified.Note: in section h6, the codes for investigation findings and investigation conclusion have been updated.Manufacturer information in section d3 has been corrected.

• Brand Name: ATELLICA IM HBC TOTAL 2 (HBCT2)
• Type of Device: TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD.; glyn rhonwy; llanberis; caernarfon NY LL554 EL; UK LL554EL
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 333 coney st.; east walpole MA 02032
• Manufacturer Contact: barry memishian ; 333 coney st.; east walpole, MA 02032 ; 5082985306
• MDR Report Key: 18085150
• MDR Text Key: 327770380
• Report Number: 1219913-2023-00283
• Device Sequence Number: 1
• Product Code: LOM
• UDI-Device Identifier: 00630414604138
• UDI-Public: 00630414604138
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P210019
• 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: 11/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 11200739
• Device Lot Number: 008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2023
• 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: 28 YR
• Patient Sex: Male