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

Model Number	N/A
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A customer from outside the united states reported observation of a nonreactive (negative) anti-hepatitis b core total (hbct) result which was discordant relative to alternate-method testing.Hbct lot information was requested, but not provided.Siemens reviewed the available reagent, instrument, and sample data.Reagent issues and instrument performance problems were ruled out as quality control (qc) results were within acceptable ranges and no issues were reported with other patient samples.The clinical sensitivity section of the atellica im anti-hepatitis b core total (hbct) instructions for use (ifu) indicates that the 95% confidence interval (ci) for resolved sensitivity as 99.09% - 100%, so a certain number of false negative results can be expected for the hbct assay.Based on the available information, the observed discordant result for this one sample is consistent with expected assay performance.Based on the investigation, no product problem was identified.The customer is operational, and no further action is required.
Event or Problem Description
The customer reports observation of a nonreactive (negative) anti-hepatitis b core total (hbct) result which was discordant relative to alternate-method testing.Hbct lot information was requested, but not provided.In a retrospective comparison of assay results, one patient¿s nonreactive hbct result was identified as discordant, as two alternate-method anti-hbc methods (atellica im hbct2 and another manufacturer's method) produced positive results for the same patient.There are no allegations of patient harm, changes in treatment, or delays of diagnosis in association with the observed discordance.

• Brand Name: ATELLICA IM ANTI-HEPATITIS B CORE TOTAL (HBCT)
• 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
• 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: 17652966
• Report Number: 1219913-2023-00180
• Device Sequence Number: 6285780
• Product Code: LOM
• UDI-Device Identifier: 00630414599205
• UDI-Public: 00630414599205
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P040004-S013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/30/2023

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 Model Number: N/A
• Device Catalogue Number: 10995597
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/23/2023
• Initial Report FDA Received Date: 08/30/2023
• 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 Sex: Unknown