MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP HBSAG CONFIRMANTORY (CONF) ASSAY; HBSAG CONFIRMATORY IMMUNOASSAY

Model Number	N/A
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cause for the non-confirmed advia centaur xp hbsag confirmatory result obtained on a patient's plasma (edta) sample is being investigated by siemens.Ths instruction for use (ifu) under the interpretation for results states the following: "for diagnostic purposes and to differentiate between acute and chronic hbv infection, the detection of hbsag should be correlated with patient clinical information and other hbv serological markers.".
Event or Problem Description
A non-confirmed advia centaur xp hbsag confirmatory result was obtained on a patient's plasma (edta) sample, and considered discordant compared to a confirmed advia centaur xp hbsagii confirmatory serum sample result.The customer performed repeat hbsagii testing with a plasma sample due to the initially hbsagii confirmed reactive result.There are no reports that treatment was altered or prescribed or adverse health consequences due to the non-confirmed advia centaur xp hbsag confirmatory plasma (edta) result.
Additional Manufacturer Narrative
Siemens filed mdr on 10/10/2018 for a non-confirmed advia centaur xp hbsag confirmatory result obtained on a patient's plasma (edta) sample.10/16/2018: additional information: based on the information available, the cause for the non-confirmed advia centaur xp hbsag confirmatory result is unknown.Other hepatitis marker results for the patient are not known, and the sample is not available for further testing.Ths instruction for use (ifu) under the interpretation for results states the following: "for diagnostic purposes and to differentiate between acute and chronic hbv infection, the detection of hbsag should be correlated with patient clinical information and other hbv serological markers." the instrument is performing within specification.No further evaluation of the device is required.

• Brand Name: ADVIA CENTAUR XP HBSAG CONFIRMANTORY (CONF) ASSAY
• Common Device Name: HBSAG CONFIRMATORY IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 7952939
• Report Number: 1219913-2018-00254
• Device Sequence Number: 1380132
• Product Code: LOM
• UDI-Device Identifier: 00630414472874
• UDI-Public: 00630414472874
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P030049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2018

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: 11/07/2019
• Device Model Number: N/A
• Device Catalogue Number: 10309058
• Device Lot Number: 3119
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/19/2018
• Supplement Date Received by Manufacturer: 10/16/2018
• Initial Report FDA Received Date: 10/10/2018
• Supplement Report FDA Received Date: 11/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1