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

Model Number N/A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

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

Event Date 09/19/2018

Event Type  malfunction  

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 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.

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
• Type of Device: HBSAG CONFIRMATORY IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 7952939
• MDR Text Key: 125464331
• Report Number: 1219913-2018-00254
• Device Sequence Number: 1
• Product Code: LOM
• UDI-Device Identifier: 00630414472874
• UDI-Public: 00630414472874
• 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: 11/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 10/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1