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 07/25/2014

Event Type  malfunction  

Event Description

A false negative advia centaur xp (b)(6) result was obtained on a patient sample.The (b)(6) result was considered discordant when repeat testing was performed by the customer on their alternate advia centaur xp instrument.The repeat test results from the same sample and another sample from the same patient, all resulted (b)(6).There was no report of patient intervention or adverse health consequences due to the discordant advia centaur xp (b)(6) assay 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 plunger, syringe, tubing from the probe tip to the dilutor and the ribbon cable from the transducer printed circuit board (pcb) to the global input output board (pcb).The cse adjusted the sample probe and rp3, decontaminated the acid and base reagents and 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: 4031805
• MDR Text Key: 4841704
• Report Number: 2432235-2014-00476
• 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: 07/28/2014

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: 07/28/2014
• Initial Date FDA Received: 08/22/2014
• 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