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

Model Number ADVIA CENTAUR XP

Device Problem False Negative Result (1225)

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

Event Date 12/02/2014

Event Type  malfunction  

Event Description

A (b)(6) advia centaur xp (b)(6) result was obtained on a known (b)(6) patient.The same patient sample was repeated on the same advia centaur xp system and the (b)(6) result was (b)(6).The discordant result was not reported to the physician.There was no report of patient intervention or adverse health consequences due to the discordant, (b)(6) result.

Manufacturer Narrative

The cause for the (b)(6) advia centaur xp (b)(6) result on a known (b)(6) patient is unknown.A siemens customer service engineer (cse) was dispatched to the customer site and is currently investigating the issue.

Manufacturer Narrative

Siemens filed initial mdr 2432235-2014-00711 on 18-dec-2014 and a follow up/supplemental report with mfr report # 2432253-2014-00711 on 09-jan-2015.Correction (12-dec-2019): the mfr report # for the follow up/supplemental report should have been 2432235-2014-00711.The mfr report # was updated to reflect this information.The information documented in the follow up/supplemental report submitted on 09-jan-2015 can be found below: siemens filed the initial mdr 2432253-2014-000711 on december 18, 2014.Additional information (12/26/2014): a siemens customer service engineer (cse) was dispatched to the customer site.After evaluation of the instrument and instrument data, the cse adjusted the sample probe height.Quality control was verified by the customer, the patient samples that were run during the week were repeated and there were no observed discordant advia centaur xp hepatitis c virus (hcv) results.The cause for the discordant advia centaur xp hepatitis c virus (hcv) patient result is unknown.The instrument is operational and performing within specifications.No further investigation is required.

• Brand Name: ADVIA CENTAUR XP
• Type of Device: IMMUNOASSAY ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD.; chapel lane, swords, co.; registration number 8020888; dublin ; EI
• Manufacturer Contact: christina lam ; 511 benedict ave; tarrytown, NY 10591 ; 9145243504
• MDR Report Key: 4343427
• MDR Text Key: 5218092
• Report Number: 2432235-2014-00711
• Device Sequence Number: 1
• Product Code: MOI
• 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,User Facility,foreign,health profe
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ADVIA CENTAUR XP
• Device Catalogue Number: 078-A010-01
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/22/2011
• 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