MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR HBSAGII; HBSII IMMUNOASSAY

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	06/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A customer from outside the united states reported observation of a nonreactive (negative) advia centaur hbsagii (hbsii) result which was discordant relative to later repeat testing.The advia centaur hbsagii instructions for use (ifu) states the following, under limitations: "for diagnostic purposes, the advia centaur hbsagii test results should always be assessed in conjunction with the patient's medical history, clinical examination, and other findings." "it is recognized that the current methods for the detection of hepatitis b surface antigen may not detect all potentially infected individuals.A nonreactive test result does not exclude the possibility of exposure to or infection with hepatitis b.A nonreactive test result in individuals with prior exposure to hepatitis b may be due to antigen levels below the detection limit of this assay or lack of antigen reactivity to the antibodies in this assay." "heterophilic antibodies in human serum can react with reagent immunoglobulins, interfering with in vitro immunoassays.Patients routinely exposed to animals or to animal serum products can be prone to this interference and anomalous values may be observed.Additional information may be required for diagnosis." "patients taking biotin supplements may have false negative results with this assay.Patient samples containing biotin of greater than 75 ng/ml may produce false negative results." siemens is investigating.
Event or Problem Description
The customer reports observation of a nonreactive (negative) advia centaur hbsagii (hbsii) result which was discordant relative to repeat testing.In (b)(6) of 2021, a patient was tested for hepatitis b surface antigen using hbsii lot 238, and a result of 0.70 index (nonreactive) was obtained and reported.In (b)(6) of 2023, the patient was tested for hepatitis following abnormal liver function tests.A result of >1000 was produced using hbsii, and the sample was referred for confirmatory testing.Results confirmed a hepatitis b infection of >3 months duration.Patient clinical status indicated likely reactivation of a chronic infection, rather than an acute infection.The sample from (b)(6) of 2021 was re-tested using an alternate method, producing a positive result of 1.3 index.Viral-load testing (hbv dna by pcr) was also performed, which produced a very low positive result.These retrospective results indicate that the initial (0.7 index) negative hbsii result was incorrect when produced in 2021.There are no reports of adverse patient consequences in association with the observed result discordance.
Additional Manufacturer Narrative
Mdr 1219913-2023-00152 was initially submitted on 2023-08-03.Update, 2023-09-05: siemens has concluded the investigation.A customer from outside the united states reported observation of a nonreactive (negative) advia centaur hbsagii (hbsii) result which was discordant relative to patient testing performed about two years later.When the original (2021) sample was re-tested using an alternate method, a low-level reactive result was observed.The patient in question has a history of being immunocompromised.No additional sample from this patient was available for testing.Due to the significant amount of time between tests, patient medical history, and the observed low-level reactivity on the alternate platform, past advia centaur hbsagii results cannot be correlated to current infectious disease testing being performed.Quality control (qc) results associated with the current (2023) testing were within expected ranges.Qc data from the 2021 testing could not be examined as results were no longer available.The assay¿s instructions for use (ifu) states the following, under limitations: ¿it is recognized that the current methods for the detection of hepatitis b surface antigen may not detect all potentially infected individuals.A nonreactive test result does not exclude the possibility of exposure to or infection with hepatitis b.A nonreactive test result in individuals with prior exposure to hepatitis b may be due to antigen levels below the detection limit of this assay or lack of antigen reactivity to the antibodies in this assay.¿ the issue was resolved with routine troubleshooting, and the customer is currently operational.On the basis of the available information, no product problem was identified.

• Brand Name: ADVIA CENTAUR HBSAGII
• Common Device Name: HBSII IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer Contact: barry memishian ; 333 coney st.; east walpole, MA 02032 ; 5082985306
• MDR Report Key: 17453580
• Report Number: 1219913-2023-00152
• Device Sequence Number: 12616385
• Product Code: LOM
• UDI-Device Identifier: 00630414578170
• UDI-Public: 00630414578170
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P110041
• 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): 09/18/2023

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: 12/05/2021
• Device Model Number: N/A
• Device Catalogue Number: 10492138
• Device Lot Number: 238
• 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: 07/31/2023
• Supplement Date Received by Manufacturer: 09/05/2023
• Initial Report FDA Received Date: 08/03/2023
• Supplement Report FDA Received Date: 09/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2020
• 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: Male