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

Model Number ADVIA CENTAUR CP

Device Problem Low Test Results (2458)

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

Event Date 02/14/2014

Event Type  malfunction  

Event Description

Discordant, falsely low alpha-fetoprotein (afp) results were obtained on one patient sample upon a 1:20 dilution and neat repeat on an advia centaur cp instrument.The discordant results were not released to the physician(s), as they did not match the patient¿s clinical history.The sample was repeated on the same instrument on a 1:10 dilution and post service, resulting as expected.The sample was also sent for testing at an alternate lab and the result matched the patient¿s clinical history.It is unknown which result was reported to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant, falsely low afp 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 performed a total service visit.The cse replaced the sample syringe and performed a database cleanup, deleting results greater than 30 days old.Quality controls and a patient sample were run, resulting within range.The cause of the discordant, falsely low afp results 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; registration number: 8020888; gewerbestrasse 6, neuhausen am rheinfall 8212 ; SZ 8212
• Manufacturer Contact: cassandra kocsis ; 511 benedict avenue; tarrytown 10591 ; 9145242687
• MDR Report Key: 3678795
• MDR Text Key: 4241950
• Report Number: 2432235-2014-00231
• 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: 02/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2014
• 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: 02/16/2014
• 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