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 03/05/2024

Event Type  malfunction  

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.

Event Description

The customer reports observation of a reactive atellica im anti-hepatitis b surface antigen 2 (ahbs2) result which was discordant relative to clinical indications and alternate-method testing.Ahbs2 kit lot 164 was in use at the time.The affected patient was initially tested for ahbs2 and hepatitis b surface antigen; reactive results were obtained for both tests (which is clinically unexpected).The next day, an alternate-method result for hbsag was positive.When the sample was sent out for alternate-method anti-hbs testing, a negative result was obtained.The negative ahbs result was accepted as correct, as simultaneous reactive results for both hbs and anti-hbs is considered clinically inconsistent.There are no allegations of patient harm or other adverse consequences in association with the observed discordance.

Manufacturer Narrative

Mdr 1219913-2024-00256 was initially submitted on 28-mar-24.Update, april 2024: siemens has concluded the investigation.A customer from outside the united states reported observation of a reactive atellica im anti-hepatitis b surface antigen 2 (ahbs2) result which was discordant relative to clinical indications and alternate-method testing.Quality control (qc) results were within acceptable ranges, and no issues were observed with any other samples.Assay calibration data did not indicate any issues.On the basis of this information, general reagent issues were ruled out as a likely cause.Service was dispatched to review instrument performance and perform comprehensive instrument maintenance.There were no instrument observations to explain the identified result discordance.Sample material was not made available to permit additional testing.Although a specific cause was not identified, based on the available information, the discordant result may be attributable to a sample-specific interferent.It is noted that other hepatitis assays also produced reactive results which were inconsistent with the patient¿s clinical presentation.The assay¿s instructions for use (ifu) advises the following, under interpretation of results: ¿results of this assay should always be interpreted in conjunction with the patient¿s medical history, clinical presentation, and other findings.¿ no product problem was identified.The customer is operational, and no further action is required.Note: in section h6, codes for investigation findings and investigation conclusions have been updated.

• 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
• Manufacturer Contact: barry memishian ; 333 coney st.; east walpole, MA 10591 ; 5082985306
• MDR Report Key: 19000062
• MDR Text Key: 339286375
• Report Number: 1219913-2024-00256
• Device Sequence Number: 1
• Product Code: LOM
• UDI-Device Identifier: 00630414597836
• UDI-Public: 00630414597836
• Combination Product (y/n): N
• 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,Followup
• Report Date: 04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• 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: 10995453
• Device Lot Number: 164
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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