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

Model Number ADVIA CENTAUR XP

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/26/2014

Event Type  malfunction  

Event Description

Discordant total human chorionic gonadotropin (thcg) auto dilution results were obtained on an advia centaur xp instrument on two patients.The discordant thcg auto dilution results were not reported to the physician(s).The customer repeated the diluted samples two times on the same system.The 1:100 dilution results were reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant auto dilution thcg 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 replaced the sample probe syringe.The cse also aligned the sample probe and ran controls.The cause of the discordant thcg results is unknown.The customer ran quality controls.The instrument is performing within specifications.Further evaluation of the device is not required.

• Brand Name: ADVIA CENTAUR XP
• Type of Device: IMMUNOASSAY 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: john nelson ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242530
• MDR Report Key: 4348632
• MDR Text Key: 20657107
• Report Number: 2432235-2014-00728
• Device Sequence Number: 1
• Product Code: DHA
• 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: Other
• Type of Report: Initial
• Report Date: 11/26/2014

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: Other
• Device Model Number: ADVIA CENTAUR XP
• Device Catalogue Number: 078-A010
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/26/2014
• Initial Date FDA Received: 12/19/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/14/2007
• 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