MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA IM ANTI-HEPATITIS B CORE TOTAL (HBCT) ASSAY; 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	10/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center (ccc) and reported that discordant, non-reactive anti-hepatitis b core total (hbct) result on a patient sample using lot 190 on an atellica im 1600 analyzer.The non-reactive result was reported to the physician(s), who did not question the result.The initial sample was retested on an alternate instrument, immulite 2000 instrument, the sample produced ¿positive¿ result.The positive result was reported as the correct result to the physician(s).Quality control (qc) was acceptable on the day of the event.Siemens healthcare diagnostics is evaluating the event.
Event or Problem Description
The customer reports observation of discordant, non-reactive anti-hepatitis b core total (hbct) result on a patient sample using lot 190 on an atellica im 1600 analyzer.The non-reactive result was reported to the physician(s), who did not question the result.The initial sample was retested on an alternate instrument, immulite 2000 instrument, the sample produced a ¿positive¿ result.The positive result was reported as the correct result to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant, non-reactive hbct result.
Additional Manufacturer Narrative
Siemens filed the initial mdr: 1219913-2023-00317 on 08-dec-2023.Additional information: 24-jan-2024: a united states (us) customer reports observation of discordant, non-reactive anti-hepatitis b core total (hbct) result on a patient sample using lot: 190 on an atellica im 1600 analyzer.The non-reactive result was reported to the physician(s), who did not question the result.The initial sample was retested on an alternate instrument, immulite 2000 instrument, the sample produced a ¿positive¿ result.The positive result was reported as the correct result to the physician(s).After performing investigation on the affected sample, siemens confirmed that the sample was also hepatitis b surface antigen ii (hbsii) nonreactive, anti-hbs2 (ahbs2) reactive, and hbc igm (ahbcm) nonreactive, which when combined with the hbct reactive result suggest the patient recovered from a previous hepatitis b virus (hbv) infection.Based on siemens review of customer data, atellica im hbct lot: 190 was recovering as expected.As this sample was close to the cutoff of 0.50 index the negative result was within the normal variation expected for hbct assay.As stated in the percent agreement section of the atellica im anti-hepatitis b core total (hbct) instructions for use (ifu), the 95% confidence interval for positive percent agreement is 79.58 ¿ 87.90% for recovered sample so a certain number of false negative results can be expected.Based on the available information, the cause of the discordant result is consistent with normal assay performance.The instrument is fully operational.In section h6, the investigation finding, and investigation conclusion codes were updated.

• Brand Name: ATELLICA IM ANTI-HEPATITIS B CORE TOTAL (HBCT) ASSAY
• Common Device Name: TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 333 coney st. e; registration #: 1219913; east walpole MA 02032
• Manufacturer Contact: stacy loukos ; 333 coney st.; east walpole, MA 02032 ; 3392064073
• MDR Report Key: 18290268
• Report Number: 1219913-2023-00317
• Device Sequence Number: 6761613
• Product Code: LOM
• UDI-Device Identifier: 00630414599205
• UDI-Public: 00630414599205
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P040004-S013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/19/2024
• Device Model Number: N/A
• Device Catalogue Number: 10995597
• Device Lot Number: 27374190
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/24/2023
• Supplement Date Received by Manufacturer: 01/24/2024
• Initial Report FDA Received Date: 12/08/2023
• Supplement Report FDA Received Date: 01/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2023
• 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