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

Model Number ADVIA CENTAUR XP

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/06/2015

Event Type  malfunction  

Event Description

Discordant, falsely elevated cardiac troponin i (tni-ultra) results were obtained on three patient samples on an advia centaur xp instrument.The discordant results were not reported to the physician(s).The samples were repeated on the same instrument, resulting lower.The corrected results were reported to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant, falsely elevated tni-ultra results.

Manufacturer Narrative

The cause of the discordant, falsely elevated tni-ultra results is unknown.Siemens is investigating this issue.

Manufacturer Narrative

The initial mdr 2432235-2015-00159 was filed on april 03, 2015.Additional information (03/11/15): a siemens customer service engineer (cse) was dispatched to the customer site.After evaluation of the instrument and instrument data, the cse performed preventive maintenance service.The cse replaced the wash 1 solution lid due to a crack in the pick-up straw mounting bracket.The customer ran calibrations and quality controls.The cause of the discordant, falsely elevated tni-ultra results is unknown.The instrument is performing according to specifications.No further evaluation of the device 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 limited; registration number: 8020888; chapel lane, swords, co., dublin ; EI
• Manufacturer Contact: michael metz ; 511 benedict ave; tarrytown, NY 10591 ; 9145242223
• MDR Report Key: 4659151
• MDR Text Key: 5679706
• Report Number: 2432235-2015-00159
• Device Sequence Number: 1
• Product Code: MOI
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K971418
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2015
• 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-A011-03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/10/2011
• 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