MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XPT HEPATITIS B SURFACE ANTIGEN II (HBSII); HEPATITIS B SURFACE ANTIGEN 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	04/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer had a sample from a (b)(6) month old that recovered (b)(6) with advia centaur xpt hepatitis b surface antigen ii (hbsii) kit lot 228 but (b)(6) with two alternate methods.The sample was also: atellica im hbsii (b)(6) with kit lot 237.(b)(6).Alkaline phosphatase (alp): 316 / aspartate aminotransferase (ast): 508 / alanine aminotransferase (alt): 692 / gamma-glutamyl transferase (ggt): 189 / lactate dehydrogenase (ldh): 549 (unit: u/l).Siemens reviewed the calibration and control data provided and there is no evidence of a problem.Siemens does not have any information indicating suprax or ramnos would interfere with the advia centaur xpt hbsii assay.There is no sample that can be sent to siemens for evaluation.A search of the complaint database found no other complaints about false negatives with advia centaur xp/xpt hbsii lot 228 or atellica im hbsii kit lot 237.According to smart remote services (srs) data more than 2,000 positives samples have been tested with advia centaur xp/xpt hbsii lot 228 and more than 86,000 positive samples have been tested with atellica im hbsii kit lot 237.The sensitivity section of the advia centaur xp/xpthbsii instructions for use (ifu) (10635152 revision k, 2020-08) states: "sensitivity = 100% (403/403) 95% ci (confidence interval) = 99.09-100.00%." based on this information advia centaur xp/xpt hbsii lot 228 and atellica im hbsii kit lot 237 are performing as intended since 1 false negative result out of >2000 positive results would mean a sensitivity of >99.95% for advia centaur xp/xpt hbsii lot 228 and 1 false negative result out of >86,000 positive results would mean a sensitivity of >99.99% for atellica im hbsii lot 237.The limitations section of the advia centaur xp/xpt hbsii instructions for usue states: "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 mutant hbsag detection section of the advia centaur xp/xpt hbsii ifu lists mutations that have been tested but other mutations could lead to false negative results and states: "the mutations of diagnostic concern are those that occur in the sequence coding for "a" determinant (amino acids 124-147) within the major hydrophilic loop (amino acids 100-170) of the hbv surface antigen (hbsag).13 all immunoassays for hbsag have antibodies that bind in this region and amino acid changes in this region can lead to false negative results when these changes occur at specific antibody binding sites.14 the patient is anti-hbs positive.If the patient's antibodies are binding hbsag at the same sites where the antibodies in the advia centaur hbsii assay bind, they could block the assay from detecting a small quantity of hbsag.The cause of the discrepant results seen by the customer when using advia centaur xp/xpt hbsii lot 228 and atellica im hbsii kit lot 237 could not be determined but siemens cannot rule out pre-analytical factors, a sample issue, or normal assay performance.Based on the investigation, no product problem was identified.The customer is operational.
Event or Problem Description
The customer reported an advia centaur xpt (b)(6) surface antigen ii ((b)(6)) result for a patient sample that was (b)(6) on two alternate methods.The (b)(6) result did not agree with the clinical picture.The results were not reported to the physician.There are no reports that treatment was altered or prescribed or adverse health consequences due to the (b)(6) advia centaur xpt (b)(6) result.

• Brand Name: ADVIA CENTAUR XPT HEPATITIS B SURFACE ANTIGEN II (HBSII)
• Common Device Name: HEPATITIS B SURFACE ANTIGEN IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 11824563
• Report Number: 1219913-2021-00255
• Device Sequence Number: 1060439
• Product Code: LOM
• UDI-Device Identifier: 00630414578170
• UDI-Public: 00630414578170
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P110041
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/14/2021

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: 06/10/2021
• Device Model Number: N/A
• Device Catalogue Number: 10492138
• Device Lot Number: 228
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/19/2021
• Initial Report FDA Received Date: 05/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 3 MO