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

Model Number ADVIA CENTAUR CP

Device Problems False Device Output (1226); High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/06/2014

Event Type  malfunction  

Event Description

A discordant, falsely elevated troponin result was obtained on one patient sample on an advia centaur cp instrument.The discordant result was not reported to the physician(s).The sample was repeated on the same instrument and another advia centaur cp instrument, resulting lower.The corrected result was reported to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant, falsely elevated troponin result.

Manufacturer Narrative

A siemens customer service engineer (cse) was dispatched to the customer site.After evaluation of the instrument and instrument data, the cse replaced ring bearings, waste check valve , wash station manifold, luminometer, rotary pumps, sample syringe and diluter, reagent syringe and diluter and tubing.The cse also replaced the ionizer fan replaced to resolve signal errors.Patient samples were run, resulting as expected.The cause of the discordant, falsely elevated troponin result is unknown.The instrument is performing according to specifications.No further evaluation of the device is required.

• Brand Name: ADVIA CENTAUR CP
• Type of Device: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): STRATEC BIOMEDICAL SWITZERLAND AG; registration #: 3008494306; gewerbestrasse 6; neuhausen am rheinfall, 8212 ; SZ 8212
• Manufacturer Contact: cassandra kocsis ; 511 benedict avenue; tarrytown 10591 ; 9145242687
• MDR Report Key: 4133133
• MDR Text Key: 4942481
• Report Number: 2432235-2014-00572
• Device Sequence Number: 1
• Product Code: MMI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K971418
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 09/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ADVIA CENTAUR CP
• Device Catalogue Number: 086-A002-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/06/2014
• Was Device Evaluated by Manufacturer?: No
• 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