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	08/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A customer from outside the united states reported observation of a discordant elevated (positive) anti - hepatitis b surface antigen 2 (ahbs2) result, on a female patient sample on atellica im 1600 analyzer.The initial result was not reported to the physician(s).The sample was repeated on the same atellica im analyzer, and the results were comparable.The same sample was tested on an alternate method, which gave a lower (negative) result compared to the atellica im ahbs2 initial result.The interpretation of results section of the atellica im ahbs2 instructions for use (ifu) states: "results of this assay should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings." siemens healthcare diagnostics is investigating.
Event or Problem Description
The customer reported observation of a discordant elevated (positive) anti - hepatitis b surface antigen 2 (ahbs2) result, on a female patient sample on atellica im 1600 analyzer.The initial result was not reported to the physician(s).The sample was repeated on the same atellica im analyzer, and the results were comparable.The same sample was tested on an alternate method, which gave a lower (negative) result compared to the atellica im ahbs2 initial result.There are no known reports of patient intervention or adverse health consequences due to the discordant elevated (positive) ahbs2 patient result.
Additional Manufacturer Narrative
Siemens filed the initial mdr 1219913-2023-00167 on aug 16, 2023.Additional information sep 16, 2023: the customer reported observation of a discordant elevated (positive) anti - hepatitis b surface antigen 2 (ahbs2) result, on a female patient sample on atellica im 1600 analyzer.The initial result was not reported to the physician(s).The sample was repeated on the same atellica im analyzer, and the results were comparable.The same sample was tested on an alternate method, which gave a lower (negative) result compared to the atellica im ahbs2 initial result.Siemens investigated the customer complaint with available information.The customer was able to provide a patient history of current pregnancy.The ahbs2 quality control (qc) testing on the day of the initial testing was within range.Additional hepatitis testing was completed for the patient sample and the hepatitis b surface antigen ii (hbsii), hepatitis b e antigen (hbeag), anti-hepatitis b core total (ahbct) were also reactive (positive) on this patient's sample.Based on the result of the alternate platform testing and reactivity with hbsii, hbeag and ahbct on the atellica im, siemens cannot rule out pre-analytical factors or a sample specific interferent in the patient sample as the cause of the initial reactive testing for ahbs2.The assay is performing as expected and within specifications.The interpretation of results section of the atellica im anti - hepatitis b surface antigen 2 (ahbs2) instructions for use (ifu) states: "results of this assay should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings." return of the patient sample for further investigation is not warranted because testing was already performed on an alternate platform for confirmation.The customer is currently operational.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 st.; east walpole MA 02032
• Manufacturer Contact: louise mclaughlin ; 333 coney st.; east walpole, MA 02032 ; 7818564812
• MDR Report Key: 17555254
• Report Number: 1219913-2023-00167
• Device Sequence Number: 3584444
• Product Code: LOM
• UDI-Device Identifier: 00630414597836
• UDI-Public: 00630414597836
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 10/11/2023

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/10/2023
• Supplement Date Received by Manufacturer: 09/16/2023
• Initial Report FDA Received Date: 08/16/2023
• Supplement Report FDA Received Date: 10/11/2023
• 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: 32 YR
• Patient Sex: Female