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

Model Number ADVIA CENTAUR CP

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/05/2014

Event Type  malfunction  

Event Description

A discordant, falsely elevated troponin result was obtained upon repeat testing on one patient sample on an advia centaur cp instrument.The discordant result was not reported to the physician(s).The sample initially resulted as expected when tested on the same instrument and falsely elevated upon first repeat.The sample was repeated a second time on the same instrument, matching the result of the initial run.It is unknown if 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.Prior to cse arrival, precision testing was run on a negative patient pool.Out of the sixty samples tested, one resulted near the customer's cutoff for a positive troponin value.After evaluation of the instrument and instrument data, the cse replaced the valve manifold sample syringe and tubing, reagent probe, and a defected ring position sensor.The cse calibrated the incubation ring.The cause of the discordant, falsely elevated troponin result is unknown.Siemens is investigating this issue.

Manufacturer Narrative

The initial mdr 2432235-2014-00662 was filed on november 26, 2014.Additional information (12/16/2014): the issue has been resolved with the siemens customer service engineer's (cse) last visit.The cause of the discordant, falsely elevated troponin result is unknown.The details of the last service visit were provided in the initial mdr.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; neuwiesenstrasse 4; beringen, 8222 ; SZ 8222
• Manufacturer Contact: cassandra kocsis ; 511 benedict ave; tarrytown, NY 10591 ; 9145242687
• MDR Report Key: 4282557
• MDR Text Key: 5008264
• Report Number: 2432235-2014-00662
• Device Sequence Number: 1
• Product Code: MOI
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K971418
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 12/10/2014
• Initial Date FDA Received: 11/26/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/05/2015
• 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