MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR XP; IMMUNOASSAY ANALYZER

Model Number ADVIA CENTAUR XP

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

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

Event Date 07/22/2017

Event Type  malfunction  

Manufacturer Narrative

The cause of the discordant, false reactive rubella g result on one patient sample is unknown.Siemens is investigating the issue.

Event Description

A discordant, false reactive result for igg antibodies to rubella virus (rubella g) was obtained on one patient sample on an advia centaur xp instrument.The initial result was reported to the physician(s), who questioned it.The sample was sent to an alternate laboratory where it was tested on an alternate platform, resulting non-reactive.The non-reactive result obtained on the alternate platform was reported as a correct result to the physician(s).There are no reports of patient intervention or adverse health consequence due to the discordant, false reactive rubella g result.

Manufacturer Narrative

The initial mdr 2432235-2017-00528 was filed on september 26, 2017.Additional information (11/10/2017): the issue was reported several weeks after the incident occurred.The customer stated that the instrument is functional.A siemens headquarters support center specialist reviewed the event data and stated that no further issues have been reported and this must be considered as an isolated event.The cause of the discordant, false reactive result for igg antibodies to rubella virus on one patient sample is unknown.The instrument is performing within specifications.No further evaluation of device is required.

Manufacturer Narrative

The initial mdr 2432235-2017-00528 was filed on 26-sep-2017.The first supplemental mdr 2432235-2017-00528_s1 was filed on 29-nov-2017.Additional information (23-feb-2018): a siemens headquarters support center (hsc) specialist indicated that the sample available for in-house testing is from (b)(6) 2017 and cannot be tested, as the results could be compromised and questionable due to the sample's age and integrity.The hsc specialist concluded that the issue is considered isolated and sample specific.

• Brand Name: ADVIA CENTAUR XP
• Type of Device: IMMUNOASSAY ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS; manufacturing limited; registration number: 8020888; chapel lane, swords, co., dublin ; EI
• Manufacturer Contact: shweta gulati ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242870
• MDR Report Key: 6894805
• MDR Text Key: 88252659
• Report Number: 2432235-2017-00528
• Device Sequence Number: 0
• Product Code: LFX
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K971418
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ADVIA CENTAUR XP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/06/2017
• Initial Date FDA Received: 09/26/2017
• Supplement Dates Manufacturer Received: 11/10/2017; 02/23/2018
• Supplement Dates FDA Received: 11/29/2017; 02/28/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/11/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 41 YR