MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS ADVIA CENTAUR CP; IMMUNOASSAY ANALYZER

Model Number ADVIA CENTAUR CP

Device Problems False Device Output (1226); Incorrect Or Inadequate Test Results (2456)

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

Event Date 05/23/2014

Event Type  malfunction  

Event Description

A discordant, falsely elevated troponin ultra (tni ul) result was obtained on one patient sample on an advia centaur cp instrument.The discordant tni ul result was not reported to the physician(s).The sample was repeated on the same system, which resulted lower.The sample underwent a new centrifugation and was repeated on three alternate instruments, all resulted lower.It is unknown as to which repeat result was reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated, tni ul result.

Manufacturer Narrative

A siemens customer service engineer (cse) was dispatched to the customer site.The cse evaluated the instrument and instrument data.After instrument evaluation, the cse replaced the magnet assembly inside the incubation ring.The cause of the discordant tni ul result is unknown.The cse ran controls to verify instrument performance.The instrument is performing within specifications.No further evaluation of the device is required.

• Brand Name: ADVIA CENTAUR CP
• Type of Device: IMMUNOASSAY ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): STRATEC BIOMEDICAL SWITZERLAND AG; registration number: 300849430; gewerbestrasse 6; neuhausen am rheinfall 8212, s, ; SZ
• Manufacturer Contact: john nelson ; 511 benedict ave; tarrytown, NY 10591 ; 9145242530
• MDR Report Key: 3894678
• MDR Text Key: 15998553
• Report Number: 2432235-2014-00391
• Device Sequence Number: 1
• Product Code: MMI
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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
• Report Date: 05/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2014
• 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: 05/26/2014
• 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