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

Device Problem Mechanical Problem (1384)

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

Event Date 07/19/2017

Event Type  malfunction  

Manufacturer Narrative

The customer contacted the siemens customer care center (ccc) to report the discordant alpha fetoprotein (afp) result.A siemens customer service engineer (cse) was dispatched to the customer's site.The cse checked the reagent, which had no problems.The cse replaced all aspirate pinch valves and pinch valve tubing, all aspirate probe guides, and reagent probe 1 diluter.The cse aligned reagent probe 1 and aspirate probes to the incubation ring.The cse cleaned probes and lubricated lead screws.The cse checked dispense for acid, base, and reagent probes.The cse performed an afp precision run of 10 replicates of level 1 and level 2 controls.Quality controls (qc) were confirmed and the system was operational.The cause of the discordant afp result is unknown.The instrument is performing according to the specifications.No further evaluation of this device is required.

Event Description

A discordant, falsely high alpha fetoprotein (afp) result was obtained on one patient sample on an advia centaur xpt instrument.The discordant result was not reported to the physician(s).The same sample was tested on the same and an alternate instrument, resulting lower.The result obtained from an alternate instrument was reported to physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant afp result.

• Brand Name: ADVIA CENTAUR XPT
• Type of Device: ADVIA CENTAUR XPT
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LIMIT; chapel lane; registration number: 8020888; swords, co, dublin ; EI
• Manufacturer Contact: margarita karan ; 511 benedict ave; tarrytown, NY 10591 ; 9145243105
• MDR Report Key: 6926056
• MDR Text Key: 89745568
• Report Number: 2432235-2017-00546
• Device Sequence Number: 0
• Product Code: CDZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K041133
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/19/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/10/2015
• 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