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 Known Impact Or Consequence To Patient (2692)

Event Date 03/11/2014

Event Type  malfunction  

Event Description

A discordant, false negative c human immunovirus (chiv) result was obtained on one patient sample on an advia centaur xp instrument.The discordant chiv result was reported to the physician(s).The sample was repeated four times on an alternate instrument.It is unknown what repeat results were reported to the physician(s).There were no reports of adverse health consequences or known patient intervention due to the discordant chiv results.

Manufacturer Narrative

A siemens customer service engineer (cse) was dispatched to the customer site to evaluate the instrument and instrument data.The cse discovered reagent probe 1 displayed system errors when commencing fault finding for the chiv assay problem.The cse removed the reagent probe 1 assembly and cleaned the in-out optical sensor array.The cse also replaced a faulty separation manifold and performed a total service call on the instrument.The cse was involved with extensive troubleshooting, which required multiple customer site visits.The cause of the discordant chiv result is unknown.The cse successfully ran calibrations and qc.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; registration number: 8020888; chapel lane, swords; co. dublin, ; EI
• Manufacturer Contact: john nelson ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242530
• MDR Report Key: 3791496
• MDR Text Key: 22000929
• Report Number: 2432235-2014-00321
• Device Sequence Number: 1
• Product Code: NHS
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: Health Professional
• Type of Report: Initial
• Report Date: 04/10/2014

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: Health Professional
• Device Model Number: ADVIA CENTAUR XP
• Device Catalogue Number: 078-A010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: 1 YR
• Initial Date Manufacturer Received: 04/10/2014
• Initial Date FDA Received: 05/05/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/19/2013
• 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