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 01/09/2015

Event Type  malfunction  

Event Description

A discordant total human chorionic gonadotropin (thcg) result was obtained on one patient sample on an advia centaur xp instrument.The discordant thcg result was reported to the physician(s), who questioned it.The physician(s) notified the laboratory informing them the patient had a sonogram, which indicated the patient is pregnant.The customer repeated the initial sample on the same system, which resulted higher.The repeated thcg result was reported to the physician(s) as the corrected result.There are no known reports of patient intervention or adverse health consequences due to the discordant thcg result.

Manufacturer Narrative

A siemens customer service engineer (cse) was dispatched to the customer site.After evaluation of the instrument and instrument data, the cse determined that there were no instrument errors during the time of the event.The cse instructed the customer to repeat the sample.The customer successfully repeated the sample.The cause of the discordant thcg result is unknown.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: 4505472
• MDR Text Key: 5489519
• Report Number: 2432235-2015-00066
• Device Sequence Number: 1
• Product Code: DHA
• 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: Other
• Type of Report: Initial
• Report Date: 01/16/2015

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: 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: 01/16/2015
• Initial Date FDA Received: 02/10/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/19/2012
• 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