MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA IM ANTI-HEPATITIS B SURFACE ANTIGEN 2 (AHBS2); TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)

Model Number N/A

Device Problem False Positive Result (1227)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/15/2024

Event Type  malfunction  

Event Description

The customer reports observation of reactive atellica im anti-hepatitis b surface antigen 2 (ahbs2) results which were discordant relative to alternate-method testing.Ahbs2 kit lot 164 was in use at the time.The customer obtained reproducible reactive ahbs2 results on three test dates for a 30-year-old male patient.Repeat testing using two alternate methods produced negative results which conflicted with the earlier reactive results.The customer is uncertain which results to consider correct.Due to the conflicting indications, the reactive atellica im ahbs2 results are considered potential false positive observations.There are no allegations of any adverse patient consequences in association with the observed discordance.Quality control (qc) results were within expected ranges when these ahbs2 tests were run.

Manufacturer Narrative

A customer from outside the united sates reported observation of a reactive (positive) atellica im anti-hepatitis b surface antigen 2 (ahbs2) result which was discordant relative to alternate-method testing.The atellica im ahbs2 instructions for use (ifu) states the following, under interpretation of results: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings." siemens is investigating.

• Brand Name: ATELLICA IM ANTI-HEPATITIS B SURFACE ANTIGEN 2 (AHBS2)
• 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 ; AG 02032
• Manufacturer Contact: barry memishian ; 333 coney st.; east walpole, MA 02032 ; 5082985306
• MDR Report Key: 19033544
• MDR Text Key: 339259933
• Report Number: 1219913-2024-00280
• Device Sequence Number: 1
• Product Code: LOM
• UDI-Device Identifier: 00630414597836
• UDI-Public: 00630414597836
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K192790
• 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: 04/03/2024

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 Model Number: N/A
• Device Catalogue Number: 10995453
• Device Lot Number: 164
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/02/2024
• Initial Date FDA Received: 04/03/2024
• Date Device Manufactured: 06/07/2023
• 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: 30 YR
• Patient Sex: Male