MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. 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 01/15/2024

Event Type  malfunction  

Manufacturer Narrative

A customer from outside the united states reported observation of nonreactive (negative) atellica im hbc total 2 (hbct2) results which were discordant relative to clinical expectation and alternate-method testing.No issues were identified with assay calibration or quality control (qc), and no problems have been seen with other assays.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.

Event Description

The customer reports observation of nonreactive (negative) atellica im hbc total 2 (hbct2) results which were discordant relative to clinical expectation and alternate-method testing.Hbct2 kit lot 008 was in use at the time.Nonreactive hbct2 results for the affected patients were questioned by laboratory clinicians, and not reported.The laboratory sent the samples for repeat testing at another laboratory, using a different assay method.Conflicting positive results were produced by the alternate method and were accepted as the correct results.There are no allegations of patient harm, changes in treatment, or delays of diagnosis in association with the observed result discordance.

• 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, INC.; 511 benedict ave; tarrytown NY 10591
• 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: 18652443
• MDR Text Key: 334683805
• Report Number: 1219913-2024-00019
• Device Sequence Number: 1
• Product Code: LOM
• Combination Product (y/n): N
• Reporter Country Code: TU
• 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
• Report Date: 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2024
• 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: 02/05/2024
• 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