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

Model Number ADVIA CENTAUR XP

Device Problem False Negative Result (1225)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/07/2014

Event Type  malfunction  

Event Description

A discordant, (b)(6) result was obtained on one patient sample on an advia centaur xp instrument run with an automatic sample handling system.The (b)(6) result was considered discordant when the sample was repeated on the same instrument after being manually loaded and resulted (b)(6) multiple times.There are no reports of patient intervention or adverse health consequences due to the discordant (b)(6) result.".

Manufacturer Narrative

A siemens customer service engineer (cse) was sent to the customer site for instrument inspection.After evaluation of the instrument and instrument data, the cse replaced the sample/ancillary tower.The cause for the discordant (b)(6) 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 LTD.; chapel lane, swords, co; registration number 8020888; dublin, ; EI
• Manufacturer Contact: stephen perry ; 333 coney street; east walpole, MA 02032 ; 5086604163
• MDR Report Key: 4061372
• MDR Text Key: 4734789
• Report Number: 2432235-2014-00502
• Device Sequence Number: 1
• Product Code: OBF
• 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: Medical Technologist
• Type of Report: Initial
• Report Date: 08/12/2014

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: Medical Technologist
• Device Model Number: ADVIA CENTAUR XP
• Device Catalogue Number: 078-A011-03
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/12/2014
• Initial Date FDA Received: 09/04/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/15/2010
• 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