MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP HBSAG ASSAY; HBS IMMUNOASSAY

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/02/2017

Event Type  malfunction  

Manufacturer Narrative

Siemens healthcare diagnostics is investigating.The information for use (ifu) for the hbsag assay states in the limitations section: "for diagnostic purposes, the advia centaur hbsag 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 virus.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." udi number: the udi number is unknown.The reagent lots that were used at the time of testing per the article have not been provided.Mdr 1219913-2018-00138, 1219913-2018-00139 and 1219913-2018-00140 were filed for the same event.

Event Description

Discordant advia centaur (b)(6) results were observed for samples from the same patient when compared to the advia centaur xp hbsagii assay and two alternate methods.The customer contacted siemens healthcare diagnostics to inquire if the advia centaur hbsagii assay detects mutants.The inquiry was a result of the publication of the article "morbidity and mortality weekly report (mmwr)" managed by cdc and (b)(6).The article discusses (b)(6) test results for a hemodialysis patient that received vaccination in 2010.The patient was tested for (b)(6) at different laboratory locations and methods for the year 2010, and 2016 to 2017.According to the article, further investigation by cdc determined that the (b)(6) results with the patient samples were associated with (b)(6) antigen mutation.The patient results for the patient obtained on the advia centaur xp hbsag/hbsagii assays and the alternate method assays are from the published article "morbidity and mortality weekly report, (b)(6) antigen test results in a hemodialysis patient-(b)(6), 2017" hemodialysis patient.There was no report of adverse health consequences due to the discordant (b)(6) results.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2018-00141 on april 27, 2018.05/23/2018 additional information: an article was published "morbidity and mortality weekly report (mmwr)" managed by cdc and nebraska department of health and human services (ndhhs).The article discusses mutant detection with a particular patient sample comparing different methods and obtained false negative result using advia centaur hbsag assay on the xpt analyzer.The article has inaccuracies with advia centaur platform and advia centaur assay used with the patient sample.The advia centaur xpt was not available in the us from 2010-2016, which is the timeframe for the testing data.Also, states the assay used was the advia centaur hbsagii assay, which is incorrect.The assay used was the advia centaur hbsag assay.The author of the mmwr article worked on an erratum to resolve the inaccuracies in the article.The inaccuracies had been corrected.The cap today article "hbsag, mutation in public health spotlight" - april 19th of 2018 by anne paxton was released with correct information.The mmwr has the following erratum incorporated: vol.67, no.10 in the report "notes from the field: false-negative hepatitis b surface antigen test results in a hemodialysis patient - nebraska, 2017," in the table on page 312, the testing instrument used by laboratory facility a should have read "advia centaur xp." the article discusses under table "hbsag lab results for the case patient by facility and testing instrument" that "cap today was informed at press time that lab a was not using the advia centaur xpt at the time of the false-negatives as it first reported and is reflected in the table.It was using the advia centaur xp, which is compatible with the older hbs assay as well as the hbsii that was adapted to detect some of the common hbsag mutations.Hbsii was used at labs b and c and the nphl." the customer does not require further assistance.Mdr 1219913-2018-00138 supplemental report 1, 1219913-2018-00139 supplemental report 1, and 1219913-2018-00140 supplemental report 1 were filed for the same event.

• Brand Name: ADVIA CENTAUR XP HBSAG ASSAY
• Type of Device: HBS IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 7468001
• MDR Text Key: 107361809
• Report Number: 1219913-2018-00141
• Device Sequence Number: 1
• Product Code: LOM
• Combination Product (y/n): N
• PMA/PMN Number: P030049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 05/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2018
• 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: 03393362
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1