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

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cause for the (b)(6) advia centaur xp hbsag result is unknown.The customer's runs approximately 1500 patient samples per month, and there have been no other (b)(6) results.Quality control (qc) results have been within acceptable ranges.Siemens is investigating.The instruction for use (ifu) under the interpretation of results section states the following: "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.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.".
Event or Problem Description
A (b)(6) advia centaur xp hbsag (hbs) result was obtained on a patient sample and considered (b)(6) compared to alternate hbsag test method results.The customer performed repeat advia centaur xp hbsag testing of the patient sample and the result was (b)(6).The sample was tested on two other alternate hbsag test methods, and the results were (b)(6).The patient sample was diluted with saline, and the advia centaur xp hbsag result was (b)(6).A (b)(6) result was reported to the physician.Patient treatment was not prescribed or altered.There was no report of adverse health consequences due to the (b)(6) advia centaur xp hbsag result.
Additional Manufacturer Narrative
Siemens filed the initial mdr 1219913-2017-00177 on 08/04/2017 for a (b)(6).08/16/17 - additional information: based on the information provided this patient fits the chronic (b)(6) virus infection profile since the patient has a pre-existing medical condition (b)(6) patient), (b)(6).The affected patient is (b)(6).Siemens recommended to the customer to evaluate the patient sample by diluting with the negative quality control (qc) material, however saline was used.The patient sample is not kept onsite, and is not available for further testing.No conclusion can be drawn.The instruction for use (ifu) under the interpretation of results section states the following: "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.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 instrument is performing within specifications.No further evaluation of the device is required.

• Brand Name: ADVIA CENTAUR XP HBSAG ASSAY
• Common Device Name: HBS IMMUNOASSAY,
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 6768384
• Report Number: 1219913-2017-00177
• Device Sequence Number: 2064770
• Product Code: LOM
• UDI-Device Identifier: 00630414472867
• UDI-Public: 00630414472867
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P030049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2017

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: 02/14/2018
• Device Model Number: N/A
• Device Catalogue Number: 10309057
• Device Lot Number: 063191
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/02/2017
• Supplement Date Received by Manufacturer: 08/16/2017
• Initial Report FDA Received Date: 08/04/2017
• Supplement Report FDA Received Date: 08/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 29 YR