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

Model Number ADVIA CENTAUR CP

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/10/2014

Event Type  malfunction  

Event Description

The customer reported that a thyroid surgery was cancelled on one patient because the advia centaur cp instrument was not functioning.It is unknown when the thyroid surgery was rescheduled.There are no known reports of adverse health consequences due to the advia centaur cp instrument not functioning.

Manufacturer Narrative

A siemens customer service engineer (cse) was dispatched to the customer site.The cse evaluated the instrument and instrument data.After data evaluation, the cse determined that there were sample probe integrity errors on every sample during the time of the event.The cse tested sample pressure, calibrated the printed circuit board voltage and replaced the syringe.The cause of the system not functioning during the time of the event is unknown.The cse ran quality controls, which were within specification.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 #: 3008494306; gewerbestrasse 6; neuhausen am rheinfall 8212, ; SZ
• Manufacturer Contact: john nelson ; 511 benedict ave; tarrytown, NY 10591 ; 9145242530
• MDR Report Key: 4301954
• MDR Text Key: 5190542
• Report Number: 2432235-2014-00705
• Device Sequence Number: 1
• Product Code: MOI
• 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: 11/10/2014

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: 11/10/2014
• Initial Date FDA Received: 12/05/2014
• 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