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

Model Number ADVIA CENTAUR XP

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 04/14/2014

Event Type  malfunction  

Event Description

Discordant results were obtained on patient samples tested for vitamin b12 and ferritin on an advia centaur xp instrument.The customer did not provide patient data.The discordant results were reported to the physician(s).The samples were repeated and corrected results were reported to the physician(s).It is unknown on what instrument the samples were repeated.There are no reports of patient intervention or adverse health consequences due to the discordant results.

Manufacturer Narrative

The customer contacted the siemens technical solutions center (tsc).The customer stated that laboratory information system (lis) alerted them that the rolling mean of vitamin b12 was elevated.The customer ran quality controls (qc), and results were out-of-range.A siemens customer service engineer (cse) was at the customer site.After evaluation of the instrument and instrument data, the cse determined that the cause of discordant results was a clogged aspirate probe 4 waste tubing and pinch valve.The cse replaced the waste tubing and pinch valve.The instrument is performing according to specifications.No further evaluation of the device is required.

• Brand Name: ADVIA CENTAUR XP
• Type of Device: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS; manufacturing limited; registration number: 8020888; chapel lane, swords, co., dublin ; EI
• Manufacturer Contact: cassandra kocsis ; 511 benedict avenue; tarrytown 10591 ; 9145242687
• MDR Report Key: 3816377
• MDR Text Key: 4454669
• Report Number: 2432235-2014-00337
• Device Sequence Number: 1
• Product Code: CDD
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 04/23/2014

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 XP
• Device Catalogue Number: 078-A011-03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/23/2014
• Initial Date FDA Received: 05/16/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/12/2007
• 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