MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD. ATELLICA IM HBC TOTAL 2 (HBCT2); 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	11/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A customer from outside the united states reported observation of nonreactive (negative) atellica im hbc total 2 (hbct2) results which were discordant relative to clinical expectation and alternate-method testing.No issues were identified with assay calibration or quality control (qc), and no problems have been seen with other assays.The assay's instructions for use (ifu) states the following, under limitations: "the performance of the assay has not been established for populations of immunocompromised or immunosuppressed patients." "patient samples may contain heterophilic antibodies that could react in immunoassays to give falsely elevated or depressed results.This assay is designed to minimize interference from heterophilic antibodies.Additional information may be required for diagnosis." siemens is investigating.
Event or Problem Description
The customer reports observation of nonreactive (negative) atellica im hbc total 2 (hbct2) results which were discordant relative to clinical expectation and alternate-method testing.Hbct2 kit lot 008 was in use at the time.Initial nonreactive hbct2 results for the affected patients were questioned by laboratory clinicians, and not reported.The laboratory sent the samples for repeat testing at another laboratory, using a different assay method.Conflicting positive results were produced by the alternate method and were accepted as the correct results.There are no allegations of patient harm, changes in treatment, or delays of diagnosis in association with the observed result discordance.
Additional Manufacturer Narrative
Mdr 1219913-2023-00323 was initially submitted on 2023-12-12.A customer from outside the united states reported observation of nonreactive (negative) atellica im hbc total 2 (hbct2) results which were discordant relative to clinical expectation and alternate-method testing.No issues were identified with assay calibration or quality control (qc), and no problems had been seen with other assays.While the customer observed several instances of discordant nonreactive results, it is noted that the customer generated >12,000 patient results using hbct2 lot 008, so the observation rate is low.Siemens analysis of customer data showed that the hbct2 positive control result had declined over time, while the lot-008 reagent packs were aboard the instruments.This trend was not observed when the customer used another reagent lot (011).Siemens performed a 7-day on-board stability study in which performance of hbct2 lots 008 and 011 was evaluated with a broad set of samples.Both assay lots met applicable specifications, demonstrating that the product is performing as intended.No product problem was identified.The assay's instructions for use (ifu) states 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." notes: manufacturer information in section d3 has been corrected.In section h6, the codes for investigation findings and investigation conclusion have been updated.

• Brand Name: ATELLICA IM HBC TOTAL 2 (HBCT2)
• Common Device Name: TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD.; glyn rhonwy, llanberis; caernarfon NY LL554 EL; UK LL554EL
• 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: 18311451
• Report Number: 1219913-2023-00323
• Device Sequence Number: 15019666
• Product Code: LOM
• UDI-Device Identifier: 00630414604138
• UDI-Public: 00630414604138
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: P210019
• 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,Followup
• Report Date (Section B): 05/10/2024

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: 01/15/2025
• Device Model Number: N/A
• Device Catalogue Number: 11200739
• Device Lot Number: 008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/06/2023
• Supplement Date Received by Manufacturer: 05/08/2024
• Initial Report FDA Received Date: 12/12/2023
• Supplement Report FDA Received Date: 05/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2023
• 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