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

Model Number ADVIA CENTAUR XP

Device Problems Mechanical Problem (1384); Insufficient Information (3190)

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

Event Date 03/23/2017

Event Type  malfunction  

Manufacturer Narrative

Siemens is investigating the event.

Event Description

A discordant, falsely elevated free thyroxine result was obtained on a patient sample on an advia centaur xp instrument.The initial result was not reported out to the physician(s).The customer repeated the same sample on an alternate advia centaur xp instrument, resulting lower.The customer reported out the repeat result.There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated free thyroxine result.

Manufacturer Narrative

The initial mdr 2432235-2017-00276 was filed on april 21, 2017.Additional information (03/29/2017): the customer ran quality controls (qc) before initial and repeat testing, resulting within range.There were no instrument errors at the time of testing and calibration was valid.A siemens customer service engineer (cse) was dispatched to the customer site.The cse performed a total service call, readjust the alignment of sample probes 1 and 2 , realigned the sample probe cuvette bottom , reran the qcs , and observed the system.The cause of the discordant free thyroxine result 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: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD; registration number: 8020888; chapel lane; swords, co, dublin ; EI
• Manufacturer Contact: margarita karan ; 511 benedict ave; tarrytown, NY 10591 ; 9145243105
• MDR Report Key: 6514143
• MDR Text Key: 73461784
• Report Number: 2432235-2017-00276
• Device Sequence Number: 0
• Product Code: CEC
• 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,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2017
• 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
• Date Manufacturer Received: 03/29/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/16/2013
• 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