MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XPT HBSAGII (HBSII) ASSAY; 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	06/30/2021
Type of Reportable Event	Malfunction
Event or Problem Description
(b)(6) advia centaur xpt (b)(6) results were obtained on a patient sample and the reported result was questioned by the physician(s).The (b)(6) result was considered discordant compared to an (b)(6) viral load result obtained on an alternate (b)(6) test method (#1).A new sample was collected and tested on the same advia centaur xpt instrument, resulting (b)(6).The patient sample was run on an alternate (b)(6) test method (#2), resulting (b)(6).The (b)(6) viral load result was considered to be the correct result reported to the physician(s).There are no reports that treatment was altered or prescribed or adverse health consequences due to the discordant advia centaur xpt (b)(6) results.
Additional Manufacturer Narrative
The customer contacted the siemens customer care center (ccc) to report discordant, (b)(6) advia centaur xpt (b)(6) results from the same patient.Siemens is investigating.The instructions for use (ifu) under the limitation section states the following: "assay performance characteristics have not been established when the advia centaur hbsagii assay is used in conjunction with other manufacturers' assay for specific hbv serological markers.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.".
Additional Manufacturer Narrative
Siemens filed mdr 1219913-2021-00441 initial report on 01-sep-2021 for discordant, nonreactive (negative) advia centaur xpt hbsagii (hbsii) results on the same patient samples.08-sep-2021 correction: b3: siemens has been informed by the customer that the date of event for the first sample was (b)(6) 2021 and not on (b)(6) 2021 as originally reported.This information has been updated in b3.Additional information: b3: the date of event for the second sample was (b)(6) 2021.D8: the instrument is not serviced by a third-party.This information has been updated in d8.Siemens continues to investigate.
Additional Manufacturer Narrative
Siemens filed mdr 1219913-2021-00441 initial report on 01-sep-2021 for discordant, reactive results on a patient sample.Mdr 1219913-2021-00441 supplemental report 1 was filed on 28-sep-2021 for a date of event correction and additional information.15-oct-2021 additional information: siemens has completed the investigation.The customer had samples from a patient that recovered nonreactive with advia centaur xpt hepatitis b surface antigen ii (hbsii) reagent lot 241 but had a relatively high viral load.The initial sample was also anti-hbs positive, hbeag positive, and negative with the alternate quantitative hbsag assay test method.The patient was tested due to an unexplained elevation of liver enzymes during routine check-up, but they did not have liver cirrhosis.Through sequencing the customer was able to determine the hepatitis b surface antigen in the sample had two mutations, r122k and s143l.The customer was not able to provide a list of medications/supplements the patient was taking.Siemens reviewed the quality control (qc) data provided and there is no evidence of a system issue.The sample was sent to siemens for evaluation and an interfering substance with the advia centaur xpt hepatitis b surface antigen ii (hbsii) assay was not identified.The advia centaur xpt hbsii assay does detect some mutations as outlined in the mutant hbsag detection section of the instructions for use (ifu), however the customer observed double mutation of r122k and s143l was not recognized with the advia centaur xpt hbsii assay.The percent agreement section of the advia centaur xp/xpt hbsii instructions for use (ifu) (10635153 revisions k (ous) and l (us)) lists the 95% confidence interval (ci) for positive agreement as 92.0% - 98.8% so a certain number of false negative results can be expected for this assay.A review of the complaint database found no other complaints about false negatives with advia centaur hbsii reagent lot 241.According to field data, more than 2,000 positives samples were tested with advia centaur hbsii reagent lot 241.Based on this information, advia centaur xpt hbsii reagent lot 241 is performing as intended since one false negative result out of 2,000 positive results would mean a sensitivity of 99.95%.As stated in the limitations section of the advia centaur xp/xpt hbsii ifu: "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 cause of the false negative results seen by the customer with samples from this one patient when using advia centaur xpt hbsii reagent lot 241 is unknown, however potentially due to the mutation in the patient's hbsag.Based on the investigation, no product problem was identified.The customer is operational.The assay is performing within specifications.No further evaluation of the device is required.In section h6, the investigation findings code and the investigation conclusion code were revised.

• Brand Name: ADVIA CENTAUR XPT HBSAGII (HBSII) ASSAY
• Common Device Name: HBSII IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 12406126
• Report Number: 1219913-2021-00441
• Device Sequence Number: 17188948
• Product Code: LOM
• UDI-Device Identifier: 00630414578170
• UDI-Public: 00630414578170
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/25/2021

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: 01/08/2022
• Device Model Number: N/A
• Device Catalogue Number: 10492138
• Device Lot Number: 241
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/12/2021
• Supplement Date Received by Manufacturer: 09/08/2021; 10/15/2021
• Initial Report FDA Received Date: 09/01/2021
• Supplement Report FDA Received Date: 09/28/2021; 10/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR