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

Device Problem False Negative Result (1225)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/20/2023

Event Type  malfunction  

Manufacturer Narrative

A customer from outside the united states reported observation of a nonreactive (negative) atellica im hbc total 2 (hbct2) result which was 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 Description

The customer reports observation of a nonreactive (negative) atellica im hbc total 2 (hbct2) result which was discordant relative to clinical expectation and alternate-method testing.Hbct2 kit lot 008 was in use at the time.A nonreactive hbct2 result for the affected patient was questioned by laboratory clinicians, and not reported.The laboratory sent the sample for repeat testing at another laboratory, using a different assay method.A conflicting positive result was produced by the alternate method and was accepted as the correct result.There are no allegations of patient harm, changes in treatment, or delays of diagnosis in association with the observed result discordance.

Manufacturer Narrative

Mdr 1219913-2023-00324 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.".

• Brand Name: ATELLICA IM HBC TOTAL 2 (HBCT2)
• Type of Device: 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: 18311460
• MDR Text Key: 330945936
• Report Number: 1219913-2023-00324
• Device Sequence Number: 1
• Product Code: LOM
• UDI-Device Identifier: 00630414604138
• UDI-Public: 00630414604138
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: P210019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: 12/06/2023
• Initial Date FDA Received: 12/12/2023
• Supplement Dates Manufacturer Received: 05/08/2024
• Supplement Dates FDA Received: 05/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Sex: Male