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
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reports an observation of a false positive result on atellica im hepatitis b surface antigen antibodies 2 (ahbs2) for a patient sample compared to the clinical picture, when using reagent lot 161.The initial result was reported to the physician(s), who did not question the result.The atellica im hepatitis b surface antigen antibodies 2 (ahbs2) instructions for use (ifu) states in the interpretation of results section: "results of this assay should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings." siemens is investigating.
Event or Problem Description
The customer reports an observation of a false positive result on atellica im hepatitis b surface antigen antibodies 2 (ahbs2) for a patient sample compared to the clinical picture, when using reagent lot 161.The initial result was reported to the physician(s), who did not question the result.There are no reports that treatment was altered or prescribed or adverse health consequences due to the result.
Additional Manufacturer Narrative
Initial mdr 1219913-2023-00170 was filed on (b)(6) 2023.Additional information ¿ (b)(6) 2023: siemens investigated a customer complaint for an atellica im anti-hepatitis b surface antibody (ahbs2) falsely reactive (positive) patient sample that was also reactive on the hepatitis b surface antigen (hbsii).The customer was requesting a possible explanation for a patient sample to reactive on both assays at the same time.Siemens reviewed past escalation complaints regarding this topic and all associated information within the escalation ticket.Hbsag is a protein on the surface of the hepatitis b virus that can be detected in high levels in serum during acute or chronic hepatitis b virus infection.The presence of hbsag indicates that the person is infectious.Anti-hbs is an antibody that reflects the recovery and immunity of hosts.It is generally interpreted as indicating recovery and immunity from hepatitis b virus infection.Hbsag and anti-hbs can coexist during seroconversion and then form an immune complex, which is rarely detected in clinical cases.This coexistence is paradoxical because hbsag is a specific indicator of acute or chronic hbv infections, while anti-hbs is a protective antibody.This phenomenon has been observed in chronic hbv carriers.The customer sent this patient sample out for testing on an alternate platform, and the result confirmed the atellica im ahbs2 results.Siemens cannot rule out a sample-specific interferent or clinical issue with the patient sample as the cause of the duality of reactive results.Return of the patient sample for further investigation is not warranted because of the low sample volume and atellica results confirmed on an alternate testing platform.The customer is currently operational.The issue was resolved with routine troubleshooting.In section h6, the investigation finding and investigation conclusion codes were updated.

• Brand Name: ATELLICA IM ANTI-HEPATITIS B SURFACE ANTIGEN 2 (AHBS2)
• Common Device Name: 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 5097
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC; 333 coney street; east walpole MA 02032
• Manufacturer Contact: louise mclaughlin ; 333 coney street; east walpole, MA 02032 ; 7818564812
• MDR Report Key: 17563283
• Report Number: 1219913-2023-00170
• Device Sequence Number: 7004517
• Product Code: LOM
• UDI-Device Identifier: 00630414597836
• UDI-Public: 00630414597836
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P100039-S005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/28/2024
• Device Model Number: N/A
• Device Catalogue Number: 10995453
• Device Lot Number: 161
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/27/2023
• Supplement Date Received by Manufacturer: 08/25/2023
• Initial Report FDA Received Date: 08/17/2023
• Supplement Report FDA Received Date: 09/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Sex: Male