MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP HBC TOTAL (HBCT); HEPATITIS B VIRUS IMMUNOASSAY

Model Number N/A

Device Problem False Negative Result (1225)

Patient Problem Hepatitis (1897)

Event Date 09/23/2018

Event Type  Injury  

Manufacturer Narrative

Siemens is investigating and has requested additional information.It is alleged by the customer that an organ donor tested (b)(6) for anti-hbct.A false negative anti-hbct result for an organ donor as part of a transplant protocol may lead to a missed diagnosis of hepatitis b viral infection, which may reduce the probability of use of prophylaxis to reduce the risk of potential transmission of infection.Transmission of hbv is uncommon for kidney donors and it is not unusual for hbct-positive patients to donate non-liver organs.Hbv transmission is much more common when donating liver tissue.It is unknown if the recipient of the organ was immunized for hepatitis b, which is recommended (among other types of vaccinations) before solid organ transplant to reduce transmission risk.Use of antiviral therapy for reduced reactivation risk is dependent on hbsag status (less risk if hbsag negative) and the immunosuppression therapy being utilized, which affect the probability of reactivation.Lower risk patients (ex.Hbsag negative and certain lower risk therapies) may only be monitored for hbv reactivation prior to use of antiviral therapy.Per the intended use of the advia centaur xp assay, the anti-hbct assay is intended to be used as an aid in diagnosis, in conjunction with other hepatitis b virus serological markers.The results of other laboratory testing that is typically used in conjunction with anti-hbct during transplant assessment of donors and recipients, such as hbsag, anti-hbs, and/or hbv nucleic acid, are not known but have been requested.Clinical practice varies in use of pre- and post-transplant vaccination and antiviral treatment, which if used would mitigate the potential for injury.This event occurred in (b)(6).The (b)(6) instructions for use # 10491867 revision y states the following in the intended use section: "the advia centaur hbc total assay is an in vitro diagnostic test for the qualitative determination of total antibodies to the core antigen of the hepatitis b virus (hbc total) in human serum or edta plasma using the advia centaur, advia centaur xp, and advia centaur xpt systems.This assay can be used as an aid in the diagnosis of individuals with acute or chronic hepatitis b virus (hbv) infection and in the determination of the clinical status of hbv infected individuals in conjunction with other hbv serological markers for the laboratory diagnosis of hbv disease associated with hbv infection.This assay can also be used as an aid in the differential diagnosis in individuals displaying signs and symptoms of hepatitis in whom etiology is unknown.This assay may also be used in testing serum and plasma specimens to screen donors whose cells, tissues, and organs are intended for transplant.The advia centaur hbc total assay may only be used with specimens obtained while the donor's heart is still beating.This assay is not indicated for use with specimens from cadaveric (non-heart-beating) donors.This product is not intended for testing or screening pooled specimens from more than one individual, or for use in screening blood or plasma donors for transfusion." the above intended use has not been cleared in the united states of america (us).The us instructions for use states the following in the intended use section: "the advia centaur® hbc total assay is an in vitro diagnostic test for the qualitative determination of total antibodies to the core antigen of the hepatitis b virus (hbc total) in human neonatal, pediatric, and adult serum or plasma (potassium edta, or lithium or sodium heparinized) using the advia centaur, advia centaur xp, and advia centaur xpt systems.This assay can be used as an aid in the diagnosis of individuals with acute or chronic hepatitis b virus (hbv) infection and in the determination of the clinical status of hbv infected individuals in conjunction with other hbv serological markers for the laboratory diagnosis of hbv disease associated with hbv infection.This assay can also be used as an aid in the differential diagnosis in individuals displaying signs and symptoms of hepatitis in whom etiology is unknown." the (b)(6) instructions for use # 10491867 revision y further states the following: "the performance of the assay has not been established for populations of immunocompromised or immunosuppressed patients." "anti-hbc total assays detect both igm and igg anti-hbc responses.Most often levels of anti-hbc will coincide with detectable levels of other hbv markers.Rarely, anti-hbc may be the only detectable hbv marker.This may occur during the brief period when hepatitis b surface antigen (hbsag) has been cleared from the bloodstream and before antibodies to hepatitis b surface antigen (anti-hbs) become detectable.For this reason, the use of anti-hbc total assays to detect acute infection is not recommended.Anti-hbc total assays should be used in conjunction with other marker assays to assess current or past exposure to hbv." "assay performance characteristics have not been established when the advia centaur hbc total assay is used in conjunction with other manufacturers' assay for specific hbv serological markers." "if the quality control results do not fall within the expected values or within the laboratory's established values, do not report results." "as with all in vitro diagnostic assays, each laboratory should determine its own reference range(s) for the diagnostic evaluation of patient results.".

Event Description

A customer alleged that a (b)(6) advia centaur xp hepatitis b core total (anti-hbct) result was obtained on (b)(6) for a patient (non-cadaveric sample) who was a liver transplant donor.The complaint indicates that a liver from this donor was transplanted to a recipient who subsequently developed acute hbv infection.The donor sample was then retested on an alternate method on (b)(6) 2019 and a second alternate method on (b)(6) 2019 and weak positive results were obtained.Siemens has requested additional information from the customer, including donor and recipient clinical history.The information attributed to this event is derived from information submitted to the siemens complaint handling system and has not been verified.

Manufacturer Narrative

Siemens healthcare diagnostics filed initial mdr with the fda on 10/29/2019.Additional information from 12/12/2019: siemens healthcare diagnostics has completed the investigation into the alleged false negative hepatitis b core total (hbct) obtained on one patient sample.The initial sample was run on (b)(6) 2018 and had an advia centaur xp hbct result of 0.44 index on kit lot: 110 with a positive advia centaur xp ahbs (1000 miu/ml).Alternate method testing produced a weak positive for hbct and negative hbs on pcr.The customer provided siemens with two samples from the same patient for investigation (one plasma and one serum sample).Results on advia centaur hbct kit lot: 134 were 0.45 index and 0.38 index respectively.Based on the profile the sample could potentially be a vaccinated patient as the ahbs was positive or potentially a recovered hbv patient as the hbs is also negative.It is possible that it is a false negative on the hbct assay.As per instructions for use, 10491867 rev.Y, 2019-08, "the advia centaur hbc total assay is an in vitro diagnostic test for the qualitative determination of total antibodies to the core antigen of the hepatitis b virus (hbc total) in human serum or edta plasma using the advia centaur, advia centaur xp, and advia centaur xpt systems.This assay can be used as an aid in the diagnosis of individuals with acute or chronic hepatitis b virus (hbv) infection and in the determination of the clinical status of hbv infected individuals in conjunction with other hbv serological markers for the laboratory diagnosis of hbv disease associated with hbv infection.This assay can also be used as an aid in the differential diagnosis in individuals displaying signs and symptoms of hepatitis in whom etiology is unknown.There was no data provided that indicated that the overall sensitivity or specificity of the assay was not being met therefore there is no product non conformance identified.Based on the investigation, no product problem was identified.No further evaluation of the device is required.

• Brand Name: ADVIA CENTAUR XP HBC TOTAL (HBCT)
• Type of Device: HEPATITIS B VIRUS IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 9253137
• MDR Text Key: 180748667
• Report Number: 1219913-2019-00215
• Device Sequence Number: 1
• Product Code: LOM
• UDI-Device Identifier: 00630414498096
• UDI-Public: 00630414498096
• Combination Product (y/n): N
• PMA/PMN Number: P040004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 01/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/08/2019
• Device Model Number: N/A
• Device Catalogue Number: 10309508
• Device Lot Number: 100110
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other