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 07/01/2015

Event Type  malfunction  

Manufacturer Narrative

A siemens customer service engineer (cse) specialist was dispatched to the customer site.After evaluating the instrument, the cse found the serum buildup at the sample port and the ancillary reagent buildup at the ancillary entry port for the cuvette.The cse cleaned and replaced the sample syringe, the ancillary probe and the sleeve.The cse also found the buildup inside of a waste container.The cse cleaned and replaced the reservoir cap and fitting for the position.The cse ran precision testing, daily cleaning procedure and quality controls, all of which were acceptable.The cause of the discordant, false negative hcv result on one patient sample is unknown.The instrument is performing according to specifications.No further evaluation of the device is required.

Event Description

A discordant, false negative (b)(6) result was obtained on one patient sample on an advia centaur xp instrument.The discordant result was reported to the physician(s), who questioned it.The sample was tested using polymerase chain reaction, resulting positive.The same sample from different tube was repeated three times on the same instrument, all resulting positive.The corrected results were reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant, false negative hcv result.

• Brand Name: ADVIA CENTAUR XP
• Type of Device: IMMUNOASSAY ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS; manufacturing limited; registration number: 8020888; chapel lane, swords, dublin ; EI
• Manufacturer Contact: cassandra kocsis ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242687
• MDR Report Key: 4952326
• MDR Text Key: 24655439
• Report Number: 2432235-2015-00339
• Device Sequence Number: 0
• Product Code: OBF
• 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 faci
• Reporter Occupation: Health Professional
• Report Date: 07/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ADVIA CENTAUR XP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/30/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/05/2009
• 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