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

Model Number ADVIA CENTAUR

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 01/06/2015

Event Type  malfunction  

Event Description

Discordant cancer antigen 27.29 (ca 27.29) results were obtained on three patient samples on an advia centaur instrument.The initial results were reported to the physician(s), who questioned them.The samples were repeated on the same instrument, resulting lower.It is unknown what the corrected results were, as the samples were repeated prior to troubleshooting.It is unknown if the corrected results were reported to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant ca 27.29 results.

Manufacturer Narrative

A siemens customer service engineer (cse) was dispatched to the customer site.After evaluation of the instrument and instrument data, the cse discovered a leaking dispense 3 dilutor fitting at the manifold.The cse replaced the cracked fitting.The cse also discovered a leak at quick connect and replaced the fitting.The cse ran dispense and aspirate tests on all diluters and rinsed the system.Calibrations and quality controls were run.The cause of the discordant ca 27.29 results was due to a cracked fitting around the dispense 3 dilutor.The instrument is performing according to specifications.No further evaluation of the device is required.

• Brand Name: ADVIA CENTAUR
• Type of Device: IMMUNOASSAY ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): CHIRON DIAGNOSTICS CORPORATION; 132 artino street; oberlin OH 44074 129
• Manufacturer Contact: cassandra kocsis ; 511 benedict avenue; tarrytown 10591 ; 9145242687
• MDR Report Key: 4471218
• MDR Text Key: 15318780
• Report Number: 2432235-2015-00053
• 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: 01/07/2015

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
• Device Catalogue Number: 078-A001-08
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/07/2015
• Initial Date FDA Received: 01/30/2015
• 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