MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOTICS, INC ADVIA CENTAUR XP ANTI-HBS2 (AHBS2) ASSAY; AHBS 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 04/18/2018

Event Type  malfunction  

Manufacturer Narrative

The cause for the (b)(6) advia centaur xpt anti-hbs2 (ahbs2) result is being investigated by siemens.The instruction for use (ifu) states under the limitation section states the following: "assay performance characteristics have not been established when the advia centaur anti-hbs2 assay is used in conjunction with other manufacturers' assay for specific (b)(6) serological markers." mdr 1219913-2018-00148 was filed for a (b)(6) repeat result for sample (b)(6) run on (b)(6) 2018.

Event Description

A (b)(6) advia centaur xp anti-hbs2 (ahbs2) was obtained on a patient sample and considered discordant when compared to testing other samples from the same patient and testing on an alternate method at another site.The customer vortexed the sample, respun and retested the sample on the advia centaur xp and the result was (b)(6).Patient treatment was not prescribed or altered.There was no report of adverse health consequences due to the discordant advia centaur xp ahbs2 results.Mdr 1219913-2018-00148 was filed for a (b)(6) result for the same sample from a different day ((b)(6) 2018).

Manufacturer Narrative

Siemens filed mdr 1219913-2018-00147 on 05/17/2018 for a false positive advia centaur xp anti-hbs2 (ahbs2) patient result.05/23/2018 - additional information: the cause for discordant advia centaur xp ahbs2 result is unknown.The sample was re-spun, repeated, and resulted non-reactive (april 26th).While there is insufficient information to determine the cause of the discrepant result, the sample was observed to be slightly hemolyzed.Pre-analytic variables can affect the quality of the sample, and deviation from recommended best practices can lead to erroneous results.Pre-analytical factors or sample issue cannot be ruled out.No conclusion can be drawn.The instruction for use (ifu) states under the preparing the samples section the following: "before placing samples on the system, ensure that samples have the following characteristics: samples are free of fibrin or other particulate matter.Remove particulates by centrifugation.Samples are free of bubbles or foam." the instruction for use (ifu) states under the limitation section states the following: "assay performance characteristics have not been established when the advia centaur anti-hbs2 assay is used in conjunction with other manufacturers' assay for specific hbv serological markers." the instrument is performing within specification.No further evaluation of the device is required.Mdr 1219913-2018-00148 was filed for a falsely elevated result for the same sample from a different day (april 19, 2018), and mdr 1219913-2018-00148 supplemental report 1 was filed for additional information.

• Brand Name: ADVIA CENTAUR XP ANTI-HBS2 (AHBS2) ASSAY
• Type of Device: AHBS IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOTICS, INC; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 7524153
• MDR Text Key: 109365661
• Report Number: 1219913-2018-00147
• Device Sequence Number: 1
• Product Code: LOM
• UDI-Device Identifier: 00630414561790
• UDI-Public: 00630414561790
• Combination Product (y/n): N
• PMA/PMN Number: P100030
• 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: 06/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/25/2019
• Device Model Number: N/A
• Device Catalogue Number: 10286268
• Device Lot Number: 119083
• 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
• Patient Age: 81 YR