MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR XP

Model Number ADVIA CENTAUR XP

Device Problem Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/20/2017

Event Type  malfunction  

Manufacturer Narrative

The customer contacted the siemens customer care center (ccc) to report the discordant phenytoin result.A siemens customer service engineer (cse) was dispatched to the customer's site.The cse performed the sample probe alignments and found the sample probe to cuvette bottom alignment very high.The cse corrected alignment.The customer performed testing on the patient sample with expected results.The customer performed quality control (qc), and result was in range.A siemens headquarters support center (hsc) specialist reviewed the escalation data.Phenytoin is an inverse, small sample volume assay.If the sample is not dispensed completely, the resulting relative light units (rlu) will be lower causing a higher dose value.The poor alignment of the sample probe to cuvette bottom could cause this dilution issue.While the system is now performing as expected, the sample probe alignment issue could not be tested for verification as the cause.The cause of the discordant phenytoin result is unknown.The instrument is performing according to specifications.No further evaluation of the device is required.

Event Description

A discordant, falsely low phenytoin result was obtained on one patient sample, upon an automatic 1:2 dilution, on an advia centaur xp instrument.The sample was initially run neat, resulting above the assay range.The sample was automatically diluted by the instrument, resulting lower.The discordant results was reported to the physician(s).The customer performed a manual dilution, and the sample recovered higher.The customer repeated the manual dilution, and the result matched with the first manual dilution result.The repeat result obtained with a manual dilution was reported to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant phenytoin result.

• Brand Name: ADVIA CENTAUR XP
• Type of Device: ADVIA CENTAUR XP
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD; chapel lane; registration number: 8020888; swords, co, dublin ; EI
• Manufacturer Contact: margarita karan ; 511 benedict ave; tarrytown, NY 10591 ; 9145243105
• MDR Report Key: 6652774
• MDR Text Key: 77935317
• Report Number: 2432235-2017-00373
• Device Sequence Number: 0
• Product Code: DIP
• 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 faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/19/2017

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: 05/22/2017
• Initial Date FDA Received: 06/19/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/20/2012
• 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